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MSA EU US CTD LIST

Sr. No Product Name


Abiraterone Acetate Tablets
Acetazolamide Tablets, USP 125 mg and 250 mg
Acetylsalicylic acid 100 mg/Atorvastatin 20 mg/Ramipril 2.5/5/10 mg
Acetylsalicylic acid oral solution
Aciclovir powder for soln for infusion
Acyclovir ointment 5 % USP
Albumin Macro Aggregated inj
Alcaftadine ophthalmic solution 0.25%
Alfacalcidol soft gel capsules
Alfuzosin Hydrochloride 10mg Sustained Release Tablets
Alizapride hydrochloride 50 mg
Allopurinol 200 mg tablets
Almotriptan Malate Tablets
Amantadine Hydrochloride Capsules USP,
Ambroxol Hcl Effervecent Tablet
Amifampridine
Amikacin Sulfate
Amikacin sulfate injection USP 100mg/2ml
Aminoven Infant
Amlodipine & Valsartan Tablets
Amlodipine & Valsartan Tablets
Amlodipine 5mg 10mg Tablets
Amlodipine Besylate and Olmesartan Medoxomil Tablets
Amoxicillin + Potassium Clavulanate 500-125mg & 875-125mg Table
Amoxicillin Clavulanate Powder for inj
Amylmetacresol 2,4, Dichlorobenzyl Alcohol- Black current
Amylmetacresol 2,4, Dichlorobenzyl Alcohol- Honeylemon
Amylmetacresol 2,4, Dichlorobenzyl Alcohol- Lemon
Amylmetacresol 2,4, Dichlorobenzyl Alcohol- Orange
Anastrozole Film Coated Tablet
Apixaban Tablet 2.5, 5mg
Aprepitant 80 mg & 125 mg Hard Capsules
Argatroban 100 mg/ml infusion
Aripiprazole 10 mg
Aripiprazole 1mg/ml oral solution
Asenapine Sublingul Tablets
Atazanavir Capsules 150mg, 200mg and 300mg
Atenolol BP Tablet
Atorvastatin Calcium Tablets
Atorvastatin Calcium Trihydrate
Atorvastatin tablet
Atovaquone & Proguanil HCl Film-Coated Tablets
Azacitidine for injection, 100 mg / vial
Azelastin Hcl Opthamic soln
Azelastine Hcl 140mcg Nasal Spray
Azithromycin 250mg Capsule
Azithromycin Dispersible tablet
Azithromycin powder for solution for infusion 500mg/vial
Azithromycin Tablets 250 mg and 500 mg
Baclofen Injection
Beclometasone nasal Spray
Bendamustine Hcl 2.5 mg/ml Powder for Injection
Benfotiamine
Betahistine    Tablet
Betamethasone (0.05% & 0.1%, Cream)
Betaxolol hydrochloridum Tablet
Bezafibrate 400 mg SR Tablet
Bezafibrate 400 mg SR Tablet
Bicalutamide 150mg FCT
Bisoprolol Fumarate 5mg & 10mg Tablets
Bisoprolol Tablet

BIVALIRUDIN FOR INJECTION 250 mg/vial


Bleomycin for injection, USP 15 units per vial
Bortezomib 3.5mg Powder for Solution for Injection
Bosentan FCT
Botulinum Toxin Type A Lyopilized
Brintellix Film-coated tablets
Buccal Oral Insulin Spray
Budesonide Formoterol 160 mg/ 4.5 mcg
Budesonide Entric coated Tablet
Bupivacaine 2.5mg/ml Solution for Injection
Buprenorphine Patches
Buprenorphine Hcl + Naloxone Hcl Sublingual
Bupropion Hydrochloride Tablets USP 75 mg and 100 mg
Bupropion Tablets USP
Bupropion Tablets USP (Modified Delayed Release)
Buspirone hydrochloride
Buspirone Hydrochloride Tablets, USP 5mg, 10 mg, 15 mg and 30 m
Calcipotriol 0.005%, Betamethasone Dipropionate 0.05%
Calcium folinate Powder Soln for Inj
Calcium Levofolinate Soln for Inj
Calcium polystyrene sulfonate powder for suspension
Candesartan Cilexetil & Hydrochlorothiazide
Candesartan Cilexetil Tablets
Capecitabine Film-coated Tablets
Capsicum 0.05% cream
Captopril Tablets, USP 12.5 mg, 25 mg, 50 mg, 100 mg
Carbamazepine USP 200mg Tablet
Carboplatin 10 mg/ml Injection
Carboxyl Nethyl Celulose Eye Drops
Carfilazomib for Injection, 60 mg/vial
Carfilzomib for Injection, 60 mg/vial
Carglumic acid 200 mg dispersible tablets
Carmustine for Injection
Carvidelol Tablet
Caspofungin Acetate powder sol for inf
Cefazolin Injection
Cefepime Hcl injection
Cefixime for Oral Suspension USP, 100 mg/5 mL and 200 mg/5 mL
Cefotaxime injection
Ceftaroline Powder Conc for Solution for Infusion600 mg
Ceftazidime inj
Ceftriaxone 1G powder for Injection
Celecoxib cap
Celecoxib Cap
Celecoxib capsule
Cephalexin Tablets
CETIRIZINE 1mg/ml ORAL SOLUTION
Cetirizine Dihydrochloride
Chlorexidine digluconate 2% dermal application
Chlorhexidine 0.12 %, Oral Rinse
Chlorohexidine, Benzocaine lozenges
Chlorohexidine, Benzocaine Strong lozenges
Chlorthalidone USP 25 mg Tablet
Cholecalciferol oral drops solution
Choline alfoscerate.
Ciclopirox olamine 1 %, cream
Cilnidipine Tablets
Cilnidipine Tablets 5 mg
Cinacalcet Hydrochloride Tablets
Ciprofloxacin 2 mg/ml Solution for Infusion
Ciprofloxacin tablets 250 500 750 mg tablet
Ciprofloxacin tablets USP
Cisatracurium soln for inj/inf
Cisplatin BP 10mg/10ml, 50mg/50ml and 100mg/100ml,
Citalopram 10mg, 20mg & 40mg Tablets
Cladribine
Clarithromycin HEC
CLARITHROMYCIN powder for solution for infusion 500mg/vial
Clomiphene Citrate Tablets 50 mg
Clonidine Hcl 25 mcg Tablet
Clonidine Hydrochloride Extended-Release Tablets 0.1 mg
Clopidrogrel Tablet USP
Colecalciferol 800 IU soft Cap
Colesevelam Hydrochloride Tablets, 625 mg
Colestyramine light powder
Cyamemazine 100mg 25 mg tablet
Cyclizine 50 mg Tablets
Cyclobenzaperin ER cap
Cyclobenzaprine HCl Extended-Release Capsules, 15 mg, 30 mg
Cyclofosfamide Sol for Injection
Cytarabine 20 mgml
Dabigatran Etexilate capsules
Dabigatran Etexilate Capsules 150 mg
DAP-Penicillin powder sol for inj
Daptomycin 350 mg Powder for Solution for Injection or Infusion
Darifenacin Extended-Release Tablets
Daunorubicin Hcl for Injection USP 20 mg (Lyophilised)
Davil Cow 600 mg FCT
Deferasirox Tablets, 90 mg, 180 mg and 360 mg
Depanthol 16mg/100mg vaginal suppositories
Desflurane 100% Volatile liq for Inh.
Desloratadine- Film-coated Tablets
Desogestrel and Ethinylestradiol tablets
Desogestrel FCT
Desvenlafaxine Extended-Release Tablets
Dexamethasone 4mg/ml
Dexamethasone Sodium Phosphate eye Drops
Dexamfetamine sulfate 5mg Tablet
Dexketoprofen Injection
Dexmedetomidine hydrochloride 100 mcg
Dextromethorphan hydrobromide monohydrate
Diazepam 5 mg tablet
Diazepam 5 mg/ml solution for injection
Diclofenac diethylamine 1.16% gel
Diclofenac Eye Drop 1mg/ml Singe use 0.5ml
Diclofenac sodium 50 mg Rectal Suppository
Diclofenac Sodium and Misoprostol Tablets 50/0.2mg
Diclofenac Sodium Gel
Diclofenac Sodium injection
Dicyclomine Hydrochloride Injection USP
Dicycloverine Hydrochloride 10 mg & 20 mg/tab
Dienogest 2 mg film coated tablet
dienogest 2.0 mg/ estradiol valerate 1.0 mgFCT
DIGEODREN Granules
Digoxin Tablet 0.25 mg
Dimetindene Maleate 0.1% Drops
Dipyridamol Modified release Cap Hard
Disodium pamidronate inj
Docetaxel 20 mg/ml
Donepezil hydrochloride Tablet
Donzepezil 23mg SR
Dorzolamide + Timolol 20 mg/ml + 5 mg/ml eye drops single-dose 
Doxazosin Mesylate Tablets 1 mg, 2 mg and 4mg 
Doxepin 25 mg and 50 mg Capsules
Drospirenone 3.0 mg/Ethinylestradiol 0.020mgFCT
Droxidopa Capsules 100 mg, 200 mg and 300 mg
Duloxetine HCl DR Cap
Duloxetine hcl Gastro resistant cap
DUTASTERIDE 0.5 mg SOFT CAPSULES
Dutasteride soft capsules
Ebastine Orodispersible tablet
Efavirenz Film coated Tab
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets
Eletriptan Hydrobromide Tablets (20 mg and 40 mg)
Eletriptan Hydrobromide Tablets 20 mg and 40 mg
Emitricitabine and Tenofovir disoproxil
EMTRICITABINE CAPSULES 200MG
Enoxaparin
Enoxaparine
Enoxaperine 6K 8K 10K, 4k,2k
Entacapone Tablets USP 200 mg
Entecavir 0.5 mg FCT
Entecavir Tablets, 0.5mg
Epirubicin hydrochloride
Eplerenone Film Coated Tablet
Eptifibatide solution
Erlotinib FCT
Ertapenem Injection
Erythromycin 1 G injection
Erythropoietin PFS
Escitalopram film coated Tablets
Esomeprazole Mg Dihydrate Gastro Resistant 20mg and 40mg tablet
Esomeprazole Powder for sol inj/infu
Etoposide 20 mg/ml
Etoricoxib film-coated tablets
Etoricoxib film-coated tablets*
Everolimus 2.5 mg, 5 mg 10mg tablets
Exemestane FCT
Ezetimibe Tablets 10 mg
Ezetimibe Tablets USP 10 mg
FAMCICLOVIR FILM-COATED TABLETS
Famotidine USP Tablets
Febuxostat Tablet
Febuxostat Tablets, 40 mg and 80 mg
Fenofibrate Capsules, USP 67 mg, 134 mg and 200 mg
Fenofibrate Tablets, 54 160 mg USP
Fenofibric Acid Capsule 135mg
Fenofibric acid DR cap USP
Fentanyl citrate 0.05 mg/mL solution for injection
Fexofenadine hydrochloride120 mg Tablets
Finasteride 5 mg tablets
Fingolimod cap
Flecainide Acetate Tablets, USP 50 mg, 100 mg and 150 mg
Flucloxacillin Powder for Solution for Injection
Fluconazole infusion
Fluconazole injection
Fluconazole soln for injection
Flumazenil 0.1mgmL Solution
Fluorouracil Solution for Inj[10 mL, 20 mL, 50 mL & 100 mL fill]
Fluoxetine capsule Hard
Fluoxetine Oral Solution 20 mg / 5 mL
Fluoxetine Tablets USP
Fluticasone Propionate & Salmeterol CFC Free Inhaler
Fluticasone Propionatespray contains 50 mcg
Fosfomycin Trometamol 3 g granules
Fosphenytoin 75mg/ml injection
Frovatriptan 2.5 MG Tablet
Fulvestrant injection
Gabapentine 100mg cap
Gadobenate dimeglumine 0.5M solution for injection
Gadopentetate Dimeglumine injection
Galantamine 4mg/ml oral solution.
Ganciclovir 500mg
Geftinib FCT
Gemcitabine 10 mgml
Gemifloxacin 320 mg FCT
Gentamicin, solution for injection
Gestodene +ethylestradiol
Gliclazid sustain release
Glimepride tablet 1 2 3 4 mg
Granisetron Hydrochloride, Injectable
HeliCap 37 kBq, capsules
Heparin Solution for injection
Hydrochlorothiazide 25 mg Tablet
Hydrocortisone powder for solution
Hydrocortisone tablet
Hydroxychloroquine Sulfate Tablets, USP
Ibandronic Acid 3mg3ml
Ibuprofen chewable soft gelatin capsules
Ibuprofen Solution for Infusion
Ibuprofen 200 mg oral suspension Sachet
Ibuprofen 400 mg FCT Tablets
Ibuprofen Lysine 342 mgFCT
Ibuprofen Solution for Infusion
Ibuprofen/Paracetamol 200 mg/325 mg tablets
Icatibant 30 mg Solution for Injection in Pre-filled Syringe
Iloprost solution 10 μg/mL for inhalation
Imatinib Capsule
Imatinib Tablet 100mg 400mg
Imipenem + Cilastatin Powder for Sol
Indapamide 1.5 mg Sustained Release Tablets
Iodixanol 320 mg I/ml Solution for injection
Iohexol Intravenous 300
Iomeprol Injection
Iopamidol Injection USP
Ipratropium bromide +Salbutamol sulphate Nebuliser
Ipratropium HFA Inhaler colourless solution 20mcg
Irbesartan + HCTZ Tablet
Irbesartan Film Coated Tablet
Irinotecan Hcl trihydrate Infusion
Irinotecan Hcl trihydrate Infusion
Irinotecan Hcl trihydrate Infusion
Iron Sucrose Injection USP 20mg/ml
ISMIGEN 50mg Sublingual Tablet
Isoflurane inhalation vapour, liquid
Isoproterenol Hydrochloride Injection USP Ampoule
Isoproterenol Hydrochloride Injection USP Vials
Itraconazole Capsules
Itraconazole oral solution 10mg/ml
Kenamycin Inj
Ketamine hydrochloride Inj
KETOPROFEN 30MG Plaster
Ketorolac Trometamol 10 mg/ml Solution for Injection
Ketotifen Fumarate Ophthalmic Solution 0.025% (0.25mg/ml) 
KIT- Clarithromycin+ lansoprazole+ Tinidazole
Lacidipine FCT
Lacosamide Tablets 
Lamivudine / Zidovudine 150 / 300 mg, film-coated Tablets
Lamivudine Tablet
Lamivudine+ Nevirapine + Zidovudine 30mg 50mg 60 mg
Lamoterigine extended release tablet
Lamotrigine Oral Dispersile Tab
Lamotrigine Orally Disintegrating Tablets 25 mg, 50 mg, 100 mg an
Lamotrigine Tablets USP
Lansoprazole 15 and 30 mg Gastro-resistant capsule, hard
Lefunomide Tablets USP
Letrozole film coated
Levetiracetam Tablets
Levetiracetam Tablets 250mg, 500mg, 750mg and 1000mg
Levobupivacaine soln for infusion
Levobupivacaine soln for infusion
Levocetrizine Dihydrochloride tablet
Levodopa/Carbidopa/Entacapone FCT
Levodropropizine 30 mg/5 ml Syrup
Levofloxacin 5mg/ml soln for infu.
Levofloxacin Film Coated Tablet
Levonorgestrel + ethinylestradiol Tablet
Levonorgestrel Tablet 1.5mg
Levothyroxine Sodium 25, 50, 100, 125 mcg/5 ml Oral Soln
Lidocaine 5% Patch
Lidocaine 10mg/ml soln for infu.
Linezolid film tablet
Linezolid sol for inj
Linezolid Tablet
Lisinopril 10mg, 20mg, 30mg & 40mg
Lithium Carbonate Extended-Release Tablets
Lithium Carbonate Extended-Release Tablets, USP
Lofepramin 70mg FCT
Loratidine 10mg tablet
Lorcaserin tablet Immediate release
Losartan Potassium & Hydrochlorothiazide
Losartan Potassium & Hydrochlorothiazide Tablets USP
Losartan Potassium 25mg, 50mg & 100mg Tablets
lyophilized lactic acid bacteria
Macrogol powder for oral solution
Mefenamic 250mg and 500mg Film Coated Tablets
Megestrol acetate oral solution
Melatonin 2 mg Prolonged release Tablets
Melphalan 50 mg injection
Memantine oral solution of 5mg/pump actuation.
Memantine film-coated tablets
Memantine HCl Tablets USP
Meprobamate Tablets USP
Meropenem  powder for Sol
Metformin FCT
Metformin Hydrochloride 500 mg, 750 mg and 1000 mg Prolonged Re
Methadone oral concentrate 10mgml
Methimazole Tablets 5mg and 10mg
Methotrexate Oral Soln
Methotrexate Tablet 2.5 mg
Methylphenidate HCl modified-release capsules
Methylprednisolone powder sol for inj
Metoprolol Succinate Extended Release Tablets USP 50mg, 100mg
Metoprolol tartrate 100mg 50mg Tablet
Metoprolol tartrate SR 200 mg
Metoprolol Tartrate Tablets (Immediate release)
Metoprolol Tartrate TabletsImmediate Release
Metoprolol tratarate & Hydrochlorothiazide
Metronidazole Gel
Metronidazole 5 mg/ml Solution for Infusion
Metronidazole Capsule USP
Metronidazole Dental Gel
Metronidazole Tablets USP
Metronidazole-gel
Micafungin 50 mg, 100mg
Milrinone Lactate Injection, 1mg/ml
Minocyclin E R Tab
Mirtazapine Orodispersible Tablets
Misoprostol Tablets 200mcg
Mitomycin Solution for Injection
Mitoxantrone Concentrate Sol for Infu
Mitoxantrone hydrochloride Conc Sol inj
Modafinil Tablets USP
Mometasone furoate Nasal Spray suspension 0.05% 
Mometasone Furoate spray contains 50 microgram
Montelukast
Montelukast Chewable tab
Montelukast Sodium Chewable tab
Montelukast Sodium Oral Granules, 4mg
Moxifloxacin Ophthalmic Solution  0.5%w/v 
Moxifloxacin FCT
Mycophenolate Mofetil Capsules USP, 250 mg
Mycophenolic Acid Delayed Release Tablets 360 mg
Mycophenolic Acid Tablets
Nebivolol Tablets
Nebivolol Tablets, 2.5 mg, 5 mg, 10 mg and 20 mg
Nevirapine 400 mg Prolonged-Release Tablets
Nicorandil Tablet
Nicotin Chewing gum
Nifedipine extended release tablets 30 mg and 60 mg:
Nisoldipine ER Tablets
Nitisinone Capsule
Nitrofurantoin cap
Nitrofurantoin Capsule
Nitrofurantoin Tab
Nitroglycerin 0.5 mg sublingual tablets
Ofloxacin eye drops, solution
Ofloxacin 0.5 ml single dose
Olanzapine Film Coated Tablet
Olanzapine Orally Disintegrating Tablets
Olanzapine Tablets USP
Olmesartan & Hydrochlorothiazide Tablets
Olmesartan Medoxomil Tablets
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide
Olopatadine Ophthalmic solution USP 0.1 %
Omega-3-Acid Ethyl Esters 90 Momaja 1000mg Soft Gel Capsules
Omeprazole 10mg, 20mg & 40mg Gastro-resistant Capsules
Omeprazole Capsule
Omeprazole powder for soln for inf
Omeprazole/Sodium Bicarbonate Powder for Oral Suspension
Ondansetron 4mg & 8mg Tablets
Ondansetron hcl dehydrate Sol for Inj
Ondansetron hcl dehydrate Sol for Inj
Orlistat capsules
Ornidazole-Injection
Oseltamivir Phosphate Capsules
Oxaliplatin Powder for Sol for Inf
Oxycodone Hcl + Naloxone Hcl Prolonged release Tablet
Oxytocin injection 1 ml  
Paclitaxel Infusion
Palonosetron Hcl 250 micro soln for inj
Pamidronate disodium
Pantoprazole gastro-resistant tablets
Pantoprazole Powder injection
Paracetamol 500mg tablet
Paracetamol , CPM, phenylephrine & caffine
Paracetamol /Caffine/Codeine Phosphate tablets
Paracetamol +Ascorbic acid+ Chlorphenamine maleate
Paracetamol 400 mg, Caffeine 50 mg / Codeine phosphate
hemihydrate 20 mg tablet
Paracetamol IV Injection
Paracetamol Tablet
Paracetamol/Ascorbic acid/Chlorphenamine maleate
Paricalcitol 2 microgram/ml injection
Paroxetine Hcl Extended release Tablet
Pemetrexed for Injection, 100 mg/vial and 500 mg/vial
Perindopril Erbumine Tablet
Phloroglucinol 40 mg /4 ml Solution
Phloroglucinol 80 mg Orodispersible Tablets
Pimecrolimus Cream 1% w/w
Pinaverium Bromide Tablets 50 mg and 100 mg
Pioglitazone and Metformin Hydrochloride Tablets
Pioglitazone Hcl USP Tablet
Piperacillin + Tazobactam 2G/0.25 g Powder for soln
Polymyxin / Gramicidin 10,000 IU / 0.025 mg/ml Eye and Ear Drops 
Polyvalent Mechanical Bacterial Lysate (PMBL)
Posaconazole gastro-resistant tablets 100 mg
Posiformin 2 %, eye ointment
Pramipexole Tablet
Pramipexole Dihydrochloride Extended-Release Tablets
Pramipexole Prolonged release Tablets
Prasugrel Tablets
Prednisolone Soluble Tablets 5 mg & 10 mg
Pregabaline hard capsule
Propofol injection  filled in 20 ml / 50 ml glass vial 
Prucalopride Film Coated Tablet
Purified gamma globulin (IgG) antibodies to Rho (D) antigen.
Pyridostigmine Bromide Tablets USP 60mg
Quetiapine FCT
Quetiapine Fumarate E.R. Tablets 50 mg, 150 mg, 200 mg, 300 mg
Quetiapine Prolonged Release Tablets
Rabeprazole Sodium 10mg & 20mg Delayed-release Tablets
Raloxifene tablet 60 mg
Ramipril Tablets
Ramipril/Bisoprolol fumarate capsule hard
Ranitidine 30 mg/ml Oral Solution
Ranolazine, prolonged-release tablets
Rasagiline 1 mg tablets
Remefentanil 1mg/ml powder for inj
Resperidone Tablet
Rifaximin Film Coated Tablets
Riluzole 5 mg/ml oral suspension
Rimantadine Hydrochloride 50 mg tablets
Risedronate Sodium Tablets
Risperidone USP Tablet
Rivaroxaban Tablets
Rivastigmine tartrate capsules USP 1.5 mg, 3 mg, 4.5 mg and 6 mg
Rocuronium Solution for Injection
Ropinirol Hcl Prolonged Release
Ropinirole FC Tablets
Ropivacaine hydrochloride 10 ml sterile solution for injection
Rosuvastatin Calcium Tabelts
Rufinamide Tablets
Sclerosant inj
Sevelamer carbonate 800 mg FCT
SevofluraneCadiasun 100% Inhal vap liq
Sildenafil film-coated tablets
Simvastatin 5mg, 10mg, 20mg, 40mg & 80mg tablets
Sitagliptin and Metformin HCl Tablets
Sitagliptin phosphate Tab
Sodium acetate (trihydrate), Sodium chloride, Potassium chloride, Calcium chloride (dihydrate), Magnesium chloride hexa
Sodium hyaluronate ophthalmic solution
Sodium Polystyrene Sulfonate Powder
Sodium Tetradecyl sulphate concentrate
Solifenacin Succinate 5mg 10 mg Tablet
Stopropbarm tabletes
Stricil Solution for Injection
Stritarabine Solution
Subunit Keyhole limpet Hemocyanin (KLH)
Sugammadex sodium inj.
Sumatriptan 50mg and 100mg Tablets
Sunitinib 12.5mg; 25mg; 50mg
Tacrolimus Capsules
Tadalafil Tablets
Tadalafil Tablets
Tamsulosin hydrochloride 0.4mg Prolonged-release Capsules
Telesartan+HCTZ tablet
Telmisartan
Telmisartan and Amlodipine Tablets
Temozolomide Capsules 5mg, 20 mg, 100mg, 140mg, 180mg and 25
Temsirolimus Injection, 25 mg/mL
Tenofovir Disoproxil FCT
Terbinafine 125mg & 250mg Tablets
Tetradecyl Sulphate Injection
Thiopental 1000 mg powder for inj
Tianeptine Sodium film coated Tablet
Ticagrelor Tablets 90 mg
Tigecycline 50 mg lyophilized powder for solution
Timolol maleate eye drops
Tobramycin 300 mg / 5 ml is a solution intended for inhalation
Tobramycin 40 mgml
Tofacitinib Tablets 5 mg
Tolterodine tartrate Tablet
Topiramate Tab
Topotecan for Injection
Tramadol Hydrochloride 50mg Capsules
Tramadol/Paracetamol FCT
Tranexamic Acid Injection
Trazodone Hcl Oral Soln
Trientine Hcl 250 mg cap
Trientine Hydrochloride Capsules USP, 250mg
Trimetazidine modified release tablets
Trolamine cutaneous emulsion
Urea kit 50 mg (H. Pylori)
Ursodeoxycholic acid
Valaciclovir 500mg & 1000mg Tablets
Valsartan & Hydrochlorothiazide Tab
Valsartan Tablets
Vancomycin Hard gelatin cap.
Vardenafil 5 mg, 10 mg and 20 mg film-coated tablets
Vardenafil Hcl Orally Disintegrated 10 mg Tablet
Vardinafil Hcl orally Disintegrating Tab
Varenicline Tablets 0.5 mg and 1 mg
Venlafaxine HCl Extended release cap
Venovit capsules hard
Ventavis nebuliser solution
Vildagliptin & metformin hydrochloride film-coated tablets
Vildagliptin 50 mg Tablet
Vinorelbine infusion
Vinpocetine 5mg Tablet
Vitamin A palmitate eye ointment
Vitamin D3
Voriconazole powder sol for infu
Voriconazole Tablets 50 mg and 200 mg
Vortioxetine 5mg, 10mg, 15 mg, 20 mg tablet
WET-COMOD, eye drops
Xylometazoline hydrochloride nasal spray solution
Zoledronic acid
Zoledronic acid
Zolmitriptan Tablets
Zolpidem tartrate 10mg
Zonisamide Tablets 100mg
Zopiclone Tablets 7.5 mg
Candesartan+ Amlodipine+ Hydrochlorthiazide
Rosuvastatin + ezetimibe Tablet
Pegfilgrastim 6 mg

Filgrastim 0.3 mg/mL (vials) 0.6 mg/mL (syringes)


Frovatriptan FCT
Nicotine 1 mg/spraying oromucosal spray
Tadalafil 10 mg and 20 mg orodispersible films
Lacosamide 10 mg/mL, Solution for Infusion
Teriflunomide 14 mg
Hydralazine Hydrochloride Injection USP 20 mg/ml
Pelargonium dried extract Syrup
Strength BE Study Region
250 mg, 500mg Film Coated Tablets Available EU
Tablets, USP 125 mg and 250 mg Available US
HardCapsule Avilable GCC
300 mg Oral Solution Reference Data EU
500, 250 mg t Type I Tubular glass vial Reference data EU
5% Reference data US
10ml Reference Data TGA
Eye Drop 0.25% M1,2,3 US
1, 0.5, 0.25 micro Reference Data EU
10mg Sustained Release Tablets Avilable EU
2ml Ampule Reference Data GCC
200 mg tablets Available EU
Tablets 6.25 mg and 12.5 mg Available US
100 mg Available US
60 mg Reference data EU
Tablets 250 mg Reference data EU
INJECTION USP 100mg/2ml glass vail Reference Data EU
injection USP 100mg/2ml Reference Data Ukraine
10%, Solution for Infusion Reference Data EU
5/80, 5/160, 10/160 mg Available EU
10/320 mg, 5/320, 10/160, 5/160, 5/80, 5/1 Available US
5mg 10mg Tablets Available EU
5/20 mg, 10/20 mg, 5/40 mg and 10/40 mg Available US
500-125mg & 875-125mg Tablets Available EU
500 mg 100mg inj, 1000 mg 200mg inj Reference data EU
Lozenges Reference Data EU
Lozenges Reference Data EU
Lozenges Reference Data EU
Lozenges Reference Data EU
1mg Avilable EU
2.5, 5mg Avaiable US
80 mg&125 mg Hard Capsules Available EU
100 mg/ml infu Reference data EU
5 mg, 10 mg, 15, 20, 30 mg Tablet Avialable EU
EU
10 mg 5mg. Available US
Capsules 150mg, 200mg and 300mg Available EU
100mg Reference Data Malaysia
80mg, 40mg, 20mg, 10g Available EU
10mg, 20mg, 40mg, 80mg tablet Available Canada
20 mg Avilable Ethiopia
62.5mg/25mg & 250mg/100mg FCT Module 2, 3
injection 100 mg / vial Reference Data US

140mcg Nasal Spray Reference Data EU


250mg Capsule Reference Data CTD
100 mg Uganda
 infusion 500mg/vial Module 1,2,3 Canada
Tablets 250 mg and 500 mg Available EU
0.05 mg, 0.5mg, 1 mg 2 mg 3 mg/ ml Reference Data EU
50 mic Reference data EU
2.5 mg/ml (100 mg/vial) 50 mL amber colourReference Data EU
300 mg film-coated tablet Not Applicable EU
16 mg, 8mg Avilable GCC
0.05% & 0.1%, Cream Pilot Canada
20 mg Tablet Available EU
 400 mg SR FCT Available Canada
400mg SR Tablet Available Canada
150 mg, 50mg Avilable EU
5mg & 10mg Tablets Available EU
Tablet Available EU
Reference Data EU
INJECTION 250 mg/vial 10 ml Type I glass
vial with 20 mm rubber stoppers and
aluminium flip-off tear-off seal.
injection USP 15 units per glass vial Module 1,2,3 US
3.5 mg Solution for Injection Reference Data EU
125 mg, 62.5 mg Avilable EU
50 U, 100 U Soln for inj Available EU
5 mg, 1 0 mg, 15 mg and 20 mg FCT Available EU
Inhalation Reference Data GCC
Inhaler 160/ 4.5 mcg Available EU
3 mg Avilable US
2.5 mg/ml, 5 mg/ml Injection Reference EU
5mcg/h 10mcg/h Available EU
8mh/2mg, 2mg/0.5mg Tablet Avilable US
75 mg and 100 mg Tablets Available US
100 mg, 75mg Available EU
300 mg, 150 mg Available US
5 mg, 10mg Reference data EU
USP 5mg, 10 mg, 15 mg and 30 mg Available US
Ointment Referene data GCC
200 Mg, 100mg Avilable EU
10 mg/ml Reference data EU
15 g 400 g Reference EU
32/25 mg, 32/12.5 mg, Available EU
32 mg, 16mg, 8mg, 4mg Available CA
500mg, 300mg, 100 mg Avilable EU
0.05% cream Reference Data EU
Tablets 12.5 mg, 25 mg, 50 mg, 100 mg Available US
200mg Tablet Avilable US
10 mg/ml Injection Reference data EU
0.5 w/v Mosambique
Injection, 60 mg/vial 50 mL glass vial type I Module 1,2,3 US
Injection, 60 mg/vial Module 1,2,3 US
200 mg dispersible tablets Available EU
Injection USP [100mg/vial] Reference Data GCC
12.5 mg , 25mg Avilable EU
70 mg, 50mg Reference Data EU
2 G, 1G Reference Data EU
1G, 2G Vail Reference Data EU
Oral Susp100 mg/5 mL, 200 mg/5 mL Available US
1G, Reference Data Jordan
600mg Infusion Reference data EU
0.5, 1, 2g. EU
2G, 1G, 500mg Injection Reference data EU
200 mg, 100 mg Available EU
200mg Available US
200mg Avilable GCC
Tablets USP 250, 500 mg Available Canada
1mg/ml ORAL SOLUTION Reference Data EU
10 mg Tablets Avilable EU
2% solution for dermal application Reference data EU
 Oral Rinse Module 1,2,3 Canada
5 mg/5mg Reference data EU
5mg/5mg Reference data EU
50mg,25 mg Tablet Avilable US
10,000 IU/ml, 25,000 IU/2.5 ml oral solutionReference Data EU
IM injection 250 mg/ml. Reference Data EU
1 %, cream M1,2,3 EU
5mg Reference Data Jordan
5mg Tablets Philippines
90 mg, 60 mg, 30 mg  Avilable US
2 mg/ml Solution for Infusion Reference Data EU
250 500 750 mg tablet Avilable EU
250 mg, 500mg Uganda
20mg, 10mg, 5mg, 1mg/ml Reference data EU
Injection BP 10mg/10ml, 50mg/50ml and 100mg/100ml, EU
10mg, 20mg & 40mg Tablets Avilable EU
1mg/ml Reference data EU
500 mg Avilable EU
powder for solution for infusion 500mg/vial Reference Data EU
Tablets 50 mg Available Canada
25 mcg Tablet Module 1,2,3
Extended-Release Tablets 0.1 mg Available US
75mg Avilable US
800 IU soft Cap Reference data EU
Tablets, 625 mg Available US
4g oral suspension Available EU
100mg 25 mg Tablet Avilable EU
50 mg Tablets Available EU

Capsules, 15 mg, 30 mg Available US


2g, 1g, 500 mg Reference data EU
20 mg ml Reference data EU
75 mg, 110 mg, 150 mg Capsule Available CA
75mg, 150 mg capsule Available US
0.4mg/0.5mg Reference data EU
350 mg, 500mg Injection or Infusion glass vaReference Data EU
7.5 mg, 15 mg Tablet Available US
Injection USP 20 mg (Lyophilised) Module 1 2 3 GCC

Tablets 90 mg, 180 mg &360 mg Available US


Vaginal Suppositories Reference Data CTD
Inhalation EU
5 mg Avilable EU
150 micrograms and 20 micrograms Available EU
750 mcg Available EU
100 mg, 50mg Available US
4mg/ml colourless glass ampoule Reference data EU
1mg/ml Eye drops Reference EU
5mg Tablet Biowaver EU
50 mg/2ml Reference Data EU
100 mcg/ml injection Module 1,2,3 Australia
15 mg and 30 mg tablets Avilable EU
5 mg tablet Avilable EU
5 mg/ml solution for injection Reference Data EU
1.16% gel Reference Data EU
Reference Data EU
50 mg Rectal Suppository Reference Data EU
Tablets 50/0.2mg Available EU
1% gel Reference Data Myanmar
25 mg/ml Reference Data Belarus
INJECTION USP, 10 mg/mL 2 mL clear vial Module 1,2,3 US
10 mg & 20 mg Tablet Available EU
2mg film coated tablet Available EU
2.0 mg/1.0 mg FCT Available EU
Granules Reference Data EU
Tablet 0.25 mg, 0.125 mg, 0.0625 mg Available Canada
0.1% Drops Reference Data GCC
200 mg Avilable EU
90mg, 60mg 30 mg 20ml vail 1st hydrolytic cReferece Data EU
20 mg/ml Reference data EU
10 mg, 5mg Avilable CA
23 mg SR Tablet Available EU
Eye drops single-dose  Module 1,2,3 Canada
1 mg, 2 mg and 4mg Tablet Available Canada
25 mg 50 mg Capsules Available EU
3.0 mg/ 0.020 mg Film-coated tablets, 3.0 Avialable EU
Capsules 100 mg, 200 mg and 300 mg Available US
60 mg, 40, 30, 20, mg Available EU
60 mg, 30 mg EU
0.5mg Soft Cap Available EU
0.5mg Avilable EU
10 mg 20 mg ODT Available EU
600mg Fct Avilable EU
600 mg/200 mg/300 mg Available Canada
Tablets 20 mg and 40 mg Available US
Tablets 20 mg and 40 mg Available US
200mg/245mg Tablet Available EU
CAPSULES 200MG (Form I) Available US
150, 100 mg/ml Avilable EU
300 mg/3ml Avilable EU
10,000 IU Reference data EU
Tablets USP 200 mg Available US
0.5 mg, 1mg FCT Available EU
Tablets 0.5mg Available CA
2 mg/ml solution for injection Reference Data EU
50 mg 25mg Avilable EU
2mg/ml, 0.75mg/ml Reference data EU
150 mg, 100mg, 25mg Available EU
1G injection Reference EU
1G injection Reference Data EU
Pre-Filled Syringes with Needle Guard M1,2,3 EU
20, 15, 10, 5 mg Avilable EU
20mg, 40 mg gastro resistant tablet Available EU
40 mg Reference data EU
20 mg/ml Reference data EU
120mg, 90, 60, 30 mg Avilable EU
60, 90, 120 mg* Avilable EU*
Available EU
25 mg Avilable EU
Tablets 10 mg Available CA
Tablets USP 10 mg Available Canada
TABLETS 125mg/250mg/500mg/750mg Avilable EU
40 mg, 20mg US
120 mg , 60mg Available EU
40 mg, 80 mg Tablets Available US
67 mg, 134 mg and 200 mg Cap Available US
54 and 160 mg Tablets Available US
135 mg capsule Reference EU
135 mg, 45mg Available US
0.05 mg/mL solution for injection Module 1,2,3 Canada
120 mg, 180 mg Tablets Available EU
5 mg tablets Available EU
0.5 mg Available EU
Tablets 50 mg,100 mg,150 mg Available US
250 mg, 500mg, 1000 mg Injection Reference Data EU
100 mg per vail Referece Data EU
Reference Data Ethiopia
100mg /50ml Reference Data EU
0.1mg/mL Reference data EU
50 mg/ml Type 1 glass vail Reference data EU
20 mg Reference data EU
Oral Solution 20 mg / 5 mL Module 1,2,3 (Biowaver) Canada
30 mg, 10mg Available US
250/25 mic Avilable EU
spray 50 mcg amber coloured glass bottle Available EU
3 G oral solution Reference Data EU
75mg/ml inj
Tablet 2.5 mg Available CA
250mg/ml 5-mL single-dose prefilled syring Reference Data EU
400mg, 300mg, 100mg cap Avilable EU
0.529 g/mL Reference Data EU
Reference Data Malaysia
4mg/ml Reference Data EU
500mg Reference data EU
250 mg FCT Avilable EU
10 mg/ml Reference data EU
320 mg FCT Avilable GCC
40mg/ml solution for injection ReferenceData EU
75 mcg / 20 mcgTablet Available EU
30mg Tablet Avilable EU
1mg, 2mg, 3mg & 4mg Tablets Available EU
0.1mg/mL injection Module 1,2,3 US
37 kBq Capsule Clinical Report EU
5000 UI ml Refeference data EU
25 mg Tablet Module 1,2,3 EU
250 mg, 100mg Reference Data EU
10 mg tablet Available EU
200 mg Tablet Available CA
3mg/3ml Reference data EU
100 mg 50 mg Soft Gel chewable Available EU
600mg/ 100ml Reference data EU
200 mg, 400mg Avilable EU
400 mg FCT, 600mg Avilable EU
684mg, 342 mg FCT Available EU
400mg/100ml Reference data EU
200 mg/325 mg tablets Reference Data EU
30 mg Soln for Inj Pre-filled Syringe Reference Data EU
10 μg/mL for inhalation Reference Data EU
400 mg, 100 mg Avilable EU
100mg 400mg Avilable EU
500mg+ 500mg, 250mg + 250 mg Reference data EU
1.5 mg Sustained Release Tablets Available EU
Reference Data EU
Contras Media
50,75,100,150,200,250,500 ml. Reference Data EU
300 370 mg Reference Data EU
500mcg/2.5mg Soln Neb Reference data EU
20mcg HFA Inhaler Soln Available EU
150/12.5, 300/12.5, 300/25 Tablet Available EU
300 mg, 150mg, 75mg Avilable EU
100mg/5ml Reference data EU
40mg/2ml Reference data EU
20mg/ml Reference data EU
20mg/ml Reference CTD
50mg Sublingual Tablet Available GCC
inhalation vapour, liquid Reference Data EU
USP, 0.2 mg / mL & 1 mg / 5 mL(0.2 mg / m Reference Data US
0.2mg/mL (1mL and 5mL Vials) Reference Data US
100 mg Available US
oral solution 10mg/ml Module 1,2,3 Canada

50 mg/ml
30 mg Plaster Reference Data GCC
10 mg/mL Reference Data EU
Ophthalmic Solution 0.025% Module 1,2,3 Canada
Tablet (KIT) Reference Data CTD
2mg, 4mg, 6mg FCT Available EU
50mg, 100mg, 150, 200mg Tab Module 1,2,3 Canada
150 /300 mg FCT Available CA
150mg Avilable US
Tablet for oral suspension Available US
50 mg Avilable EU
25mg, 50mg, 100mg & 200mg Tablets Available EU
ODT 25 mg, 50 mg, 100 mg and 200 mg Available US
200 mg, 150mg, 100mg, 25mg Available US
15, 30 mg GR Capsule Available EU
20 mg, 10mg Available US
2.5mg Avilable EU
1000mg, 750mg, 500mg,250mg Avilable EU
Tablets 250mg, 500mg, 750mg and 1000m Available US
1.25 mg/ml Reference data EU
7.5, 5, 2.5, 0.625 mg/ml Reference data EU
5 mg tablet Available EU
50+12.5+200 , 100+25+200, 150+37.5+200, Avilable EU
30 mg/5 ml Syrup Biowaver EU
5mg/ml Reference data EU
500 mg, 250 mg Avilable EU
100 mcg/ 20 mcg Tablet Available EU
1.5 mg Tablet Available EU
25,50,100,125mcg/5ml OralSoln Reference EU
Patch 5% Available US
50mg, 20 mg, 10mg/ml Reference data EU
600 mg Reference data EU
2mg/ml Reference data EU
600 mg Available EU
10mg, 20mg, 30mg & 40mg Tablets EU
Extended-Release Tablets 300 mg Available US
300 mg ER Tablet Available US
70mg FCT No BE EU

10mg IR Tablet Available US


50mg/12.5mg,100mg/12.5mg,100mg/25mg Available EU
100/25 mg, 100/12.5, 50/12.5 mg Available US
25mg, 50mg & 100mg Tablets Available EU
Capsule Module 1 and 3
6.86 g/13.72 g Reference data EU
250mg 500mg FCT Available EU
40mg/ml Avilable EU
2 mg Prolonged release Tablets Available EU

oral soln of 5mg/pump actuation. Reference Data EU


20mg, 10 mg Reference data EU
20 mg, 10 mg Available US
400 mg, 200 mg Reference Data US
1000 mg Inj, 500 mg Reference data EU
1000mg, 850 mg, 500 mg Avilable EU
500mg, 750mg, 1000mg Prolonged Release Available EU
oral concentrate 10mgml Module 1,2,3 Canada
Tablets 5mg and 10mg Available Canada
2mg/ml Oral Solutin Avilable EU
2.5 mg Tablet Avilable EU
10, 20,30, 40, 60 mg Capsule Available EU
125mg, 40mg Type-I Glass Vial Reference data EU
Extended Release Tab 50mg, 100mg 200mg Available US
100 mg 50mg tablet Available EU
200mg SR Tablet Avilable EU
25, 50 100mg Tablet (IR) Available Canada
25, 50, 100mg IR Tablet Available CA
100/50 mg, 100/25, 50/25 mg Available EU
Reference Data Ethiopia
5 mg/ml Solution for Infusion Module 1 2 3 EU
375 mg Available US
Reference Data Ethiopia
500 mg, 250 mg Available US
Gel Ethiopia
50mg, 100mg Soln for Infusion Reference Data EU
Injection, 1mg/ml Module 3 EU

15 mg, 30 mg, 45 mg ODT Available EU


Tablets 200mcg Available EU
40mg/ml Type 1 glass vail Reference data EU
2 mg/ml Reference data EU
2 mg/ml Reference data EU
200mg, 100 mg Available US
Nasal Spray susp 0.05%  Reference Data Canada
50 microgram Spray Available EU
10 mg tablet Avilable US
4 mg and 5 mg Chewable tab Avilable EU
10 mg Tanzania
Oral Granules, 4mg Available US
Ophthalmic Solution 0.5%w/v  CTD
400mg Avilable GCC
Capsules USP, 250 mg Available US
Delayed Release Tablets 360 mg Available US
360 mg Avilable US
20 mg, 10mg, 5mg, 2.5 mg Reference Data Mayanmar
Tablets 2.5 mg, 5 mg, 10 mg & 20 mg Avilable US
400 mg Prolonged-Release Tablets Available EU
20mg, 10mg Avilable EU
Chewing gum Biowaver EU
30 mg. 60 mg Tablets Available EU
34 mg, 25mg, 17.5mg,8.5mg Available US
2mg, 5mg, 10mg cap Avilable (M1 M3 M5) US
100 mg Capsule Available US
Capsule

0.5 mg sublingual tablets Reference Data EU


3mg/ml Reference data EU
0.5 ml Reference data EU
10 mg, 5mg Avilable EU
5 mg, 10 mg, 15 mg and 20 mg Tablets Available US
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 Available US
40/25 mg, 40/12.5, 20/25, 20/12.5 mg Available US
40 mg, 20mg, 10mg Available EU
Tablet 20/5/12.5 mg, 40/5/12.5 mg, 40/5/ Available US
0.1 % Refercee Data US
1000mg Avilable EU
10mg, 20mg & 40mg Capsules Available EU
40mg, 20mg,10 mg Avilable EU
40 mg Reference Data EU
20 mg/1680 mg, 40 mg/1680 mg Available US
4mg & 8mg Tablets Available EU
8mg/4 ml Reference Data EU
4 mg/2 ml Reference Dta EU
120 mg Available EU
500mg / 100ml Injection Ethiopia
30, 45, 75 mg Capsule Available CA
5 mg/ml glass vials (size: 20 mL) Reference data EU
5/2.5, 10/5, 20/10, 30/15, 40/20 mg Avilable EU
colorless solution 1 ml ampoule  Module 1,2,3 South Africa
30 mg/5 ml; 100 mg/16.7 ml; 150 mg/25 ml; 300 mg/50 ml
250 micro gram Reference data EU
3 mg/ml Reference data EU
20 mg 40 mg Tablets Available EU
40mg Reference data EU
500mg Reference data EU
500/2/25/30 Tajikistan
400 mg/50 mg /20 mg tablets Available EU
granules for oral suspension 1000 mg, 20 Reference Data EU
Clinical Report EU
400 mg /50 mg /20 mg tablet
10 mg/ml Reference Data Myanmar
1000mg Avilable EU
1000 mg /200 mg / 4 mg sachets Reference Data EU
5 microgram/ml, 2 microgram/ml s type I g Reference data EU
37.5 mg, 25mg, 12.5g Avilable EU
100 mg/vial and 500 mg/vial Reference Data EU
2mg, 4mg, 8mg Tablet Available Canada
40mg/4 ml soution for injection Reference Data EU
80 mg Orodispersible Tablets Biowaver EU
Cream 1% w/w Reference CTD
Tablets 50 mg and 100 mg Module 1,2,3 (Biowaver) Canada
Tablets 15 mg/500 mg and 15 mg/850 mg Available US
15, 30, 45 mg immediate release oral tabletsAvailable US
4g/0.50g, 2g/0.25g Reference data EU
10,000 IU/0.025 mg/ml Eye/ Ear Drops  Module 1,2,3 Canada
50 mg Tablets Reference Data GCC
Gastro-resistant tablets 100 mg Available EU
2 % eye ointment Reference Data EU
0.18, 0.70, 0.35, 0.7, 0.18, 0.088 mg Reference data EU
4.5 , 3.75, 3, 2.25, 1.5, 0.75, 0.375 mg Available EU
3.15, 2.62, 2.1, 1.57, 1.05, 0.52, 0.26mg Available US
Prasugrel 5 mg 10 mg Tablets Available EU
5mg, 10mg Soluble Reference Data EU
300, 225, 200, 150, 100, 75, 50, 25 mg Available EU
injection 20 ml and  50 ml glass vial Module 1,2,3 Canada
1mg 2mg FCT Available EU
3 , 6 20 ml Vail Reference Data GCC
Tablets 60mg Available Canada
300mg, 200mg, 150mg, 100 mg, 25mg Avilable EU
ERT 50 mg, 150 mg, 200 mg, 300 mg and 40 Available US
50mg, 150mg, 200mg, 300mg & 400mg Avilable EU
10mg & 20mg Delayed-release Tablets Avilable EU
60 mg Tablet Available US
10mg, 5mg, 2.5mg, 1.25 mg Avilable EU
10mg/10mg, 10mg/5mg, 5mg/5mg, 5mg/2.5Available EU
30 mg/ml Oral Solution Biowaver EU
375 mg,500mg, 750mg PR Tablet Available EU
1 mg Avilable EU
5, 2, 1mg/ml for inj Reference data EU

550 mg FCT Available EU


5 mg/ml oral suspension Available EU
50 mg tablets Reference Data EU
35 mg Avilable US
4, 3, 2, 1, 0.5, 0.25 mg Avilable US
10 mg Available US
capsule1.5 mg, 3 mg, 4.5 mg and 6 mg Available US
10 mg/ml Reference data EU
8mg, 6mg, 4mg,3mg,2mg Tablet Avilable EU
0.25mg 0.5mg 1mg 2, 5mg Available EU
2 mg / ml solution for injection Reference Data EU
40 mg, 20mg, 10mg, 5mg  Avilable US
100, 200 & 400 mg Tablet Available EU

800 mg FCT Avilable EU


100% Inhal vap liq Reference data EU
100 mg, 50mg, 25mg Avilable EU
5mg, 10mg, 20mg, 40mg & 80mg tablets Available EU
50 mg/500 mg, 50 mg/ 1,000 mg Tablets Available US
25 50, 100 mg tab Available US
1000 ml Infusion Module 1,2,3 EU
20, 40 mg Eye Drop Refernce Data EU
454 gm/HDPE bottle Reference Data CA
0.2%,0.5%,1%,3% Injection Reference Data EU
5mg 10 mg Tablet Available US
30mg,15 mg Reference data EU
50 mg/ml Reference data EU
20 mg/ml Reference data EU
20mg/ml vail Reference EU
200mg/2mL /vial & 500mg/5mL /vial. Reference Data EU
50mg and 100mg Tablets Available EU
12.5mg; 25mg; 50mg Available EU
1mg, 0.5 mg Cap Reference CTD
20 mg Avilable US
25 mg, 20mg, 10mg, 5mg Available EU
0.4mg Prolonged-release Capsules Available EU
40/12.5 mg, 80/12.5 mg , 80/25 mg Available EU
80mg,40mg, 20mg Avilable EU
80/10 mg, 80/5, 40/10, 40/5 mg Available EU
Capsules 5,20, 100, 140, 180, 250mg Biowaver US
Injection, 25 mg/mL Biowaver US
204mg, 163 mg,123mg FCT Available EU
125mg & 250mg Available EU
0.2, 0.5, 1 and 3% w/v Injection Reference Data EU
1000 mg for inj, 500mg Reference data EU
12.5mg Avilable EU
90 mg Available US
50 mg lyophilized powder for solution type I Module 1,2,3 EU
0.50% Eye Drop Reference Data EU
300 mg / 5 ml solution for inhalation Module 1,2,3 EU
40 mg/ml Reference data EU
Tablets 5 mg Available US
1mg, 2mg, Tablet Available CA

Injection 4 mg (base)/glass vial Biowaver US


50mg Capsules Available EU
37.5mg/325mg Reference data EU
Injection 100mg/ mL Module 1,2,3 Canada
100mg/5ml, 50mg/5 ml Available EU
250 mg Cap Available US
Capsules USP 250mg Avilable EU
35mg Avilable EU
0.67%, cutaneous emulsion Reference data EU
50 mg Kit Available EU
250mg. Reference data EU
500mg , 1000mg Tablets Available EU
320/25, 320/12.5, 160/25, 160/12.5, 80/12 Avilable US
160mg, 80mg, 40 mg Tablets Avilable EU
250mg, 125 mg Reference data EU
5 mg, 10 mg and 20 mg FCT Available Jordan
10 mg Available US
10 mg Available Canada
Tablets 0.5 mg and 1 mg Available US
225mg,150 mg, 75mg Available EU
180 mg Reference data EU
Inhalation Nebuliser Soln Reference EU
50mg/850mg, 50/ 1000 mg, FCT Available EU
50 mg Tablets Available EU
10mg/ml glass vial Reference data EU
5mg Tablets Reference data EU
Eye Ointment Module 3 EU
50000IU Tablet Reference data
200 mg Reference data EU
Tablets 50 mg and 200 mg Available US
5mg, 10mg, 15 mg, 20 mg tablet Trails EU
Eye Drop Reference Data EU
1 mg nasal spray solution Reference Data EU
0.8 mg/ml Reference data EU
5 mg/100ml Reference data EU
5 mg, 2.5 mg Available US
10 mg Tablet Available EU
100 mg Tablet Module 3 EU
Tablets 7.5 mg Available EU
capsule hard16mg/10mg/12.5mg, 16mg/5mAvailable EU
tablets, 15mg/10mg, 30mg/10mg, 40mg/1 Available EU
1 mL glass (USP Type I) single use PFS Trails (Module 3,4,5) EU
Trails (Module 3,4,5)
300 mcg/0.5 mL PFS, 480 mcg/0.8 mL PFS -
300 mcg/1.0 mL 480 mcg/1.6 mL inj. EU
2.5 mg tablet Available EU
1 mg/spraying oromucosal spray Referene data EU
10 mg and 20 mg orodispersible films Available EU
10 mg/mL, Solution for Infusion Reference Data EU
14 mg film-coated tablets Available EU
Injection USP 20 mg/ml Reference Data CTD
Syrup Module 1 and 3 Jordan

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