List Of Dossier

Dosage:Tablets
Country: EU
Format:eCTD
Product Name Modules
Amlodipine Tablets 5 and 10 mg M1,M2,M3,M4,M5
Amlodipine Valsartan Film Coated Tablets 5/80 mg, 5/160 mg, 10/160 mg M1,M2,M3,M4,M5
Anastrozole Tablets, 1mg M1,M2,M3,M4,M5
Aripiprazole Tablets 5 mg, 10 mg, 15 mg and 30 mg M1,M2,M3,M4,M5
Aripiprazole Tablets 5 mg, 10 mg, 15 mg and 30 mg M1,M2,M3,M4,M5
Atorvastatin Tablets 10 mg M1,M2,M3,M4,M5
Atorvastatin Tablets 20 mg M1,M2,M3,M4,M5
Atorvastatin Tablets 40 mg M1,M2,M3,M4,M5
Atorvastatin Tablets 80 mg M1,M2,M3,M4,M5
Betaxolol Hydrochloride Tablet, 20 mg M1,M2,M3,M4,M5
Bisoprol Fumarate Tablets, 5, 10 mg M1,M2,M3,M4,M5
Bosentan Tablets, 62.5, 125 mg M1,M2,M3,M4,M5
Bupropion Tablets USP (Modified Release), 150, 300 mg M1,M2,M3,M4,M5
Clarithromycin Prolonged Release Tablets, 500 mg M1,M2,M3,M4,M5
Desloratadine Tablets 5mg M1,M2,M3,M4,M5
Desogestrel and Ethinylestradiol Tablets 150 mcg, 20 mcg M1,M2,M3,M4,M5
Diclofenac Sodium and Misoprostol Tablets 50/0.2 & 75/0.2mg M1,M2,M3,M4,M5
Dienogest 2.0 mg/ Estradiol valerate 1.0 mg Tablets M1,M2,M3,M5
Drospirenone 3.0 mg/ Ethinylestradiol 0.020 mg Tablets M1,M2,M3,M5
Drospirenone 3.0 mg/ Ethinylestradiol 0.030 mg Tablets M1,M2,M3,M5
Erlotinib Tablets, 25, 150 and 100mg M1,M2,M3,M4,M5
Escitalopram Tablets, 5, 10, 15, and 20 mg M1,M2,M3,M4,M5
Etoricoxib Tablets, 30,60,90,120 mg M1,M2,M3,M4,M5
Etoricoxib Tablets, 30,60,90,120 mg M1,M2,M3,M4,M5
Everolimus Tablets, 2.5, 5, 10 mg M1,M2,M3,M4,M5
Exemestane Tablets 25 mg M1,M2,M3,M4,M5
Febuxostat Tablets, 60, 120 mg M1,M2,M3,M4,M5
Fexofenadine Hydrochloride Tablets, 120, 180 mg M1,M2,M3,M4,M5
Gefitinib Tablets 250 mg M1,M2,M3,M4,M5
Ibuprofen Tablets, 400 mg M1,M2,M3,M4,M5
Ibuprofen Tablets, 600 mg M1,M2,M3,M4,M5
Irbesartan & Hydrochlorothiazide 150mg/12.5mg, 300mg/12.5mg & 300mg/25mg Tablet M1,M2,M3,M4,M5
Irbesartan Tablets, 75 mg, 150 mg and 300 mg M1,M2,M3,M4,M5
Levodopa/Carbidopa/Entacapone Tablets, 50+12.5+200, 75/18.75/200, 100+25+200, 125/31.25/200, 150+37.5+200, 175/43.75/200, 200+50+200 m M1,M2,M3,M4,M5
Levonorgestrel 100 micrograms and Ethinylestradiol 20 micrograms Tablet M1,M2,M3,M4,M5
Linezolid Tablets, 600 mg M1,M2,M3,M4,M5
Memantine Hydrochloride Tablets 10, 20 mg M1,M2,M3,M4,M5
Nicorandil Tablets, 20, 10mg M1,M2,M3,M4,M5
Olmesartan & Hydrochlorothiazide Tablets, 20/12.5. 20/25, 40/12.5, 40/2 M1,M2,M3,M4,M5
Olmesartan Medoxomil Tablets, 10, 20, 40 mg M1,M2,M3,M4,M5
Oxycodone Hcl + Naloxone Hcl Prolonged Release Tablet, 5/2.5, 10/5, 20/10, 30/15, 40/20 mg M1,M2,M3,M4,M5
Dosage:Capsules
Country: EU
Format:eCTD
Product Name Modules
Alfacalcidol Soft Gelatin Capsules 0.25, 0.5, 1 mcg M1,M2,M3,M4,M5
Duloxetine HCl DR Capsules, 20, 40 mg M1,M2,M3,M4,M5
Duloxetine HCl DR Capsules, 30, 60 mg M1,M2,M3,M4,M5
Dutasteride Soft Gelatin Capsules 0.5 mg M1,M2,M3,M4,M5
Gabapentin Hard Gelatin Capsules 100, 300 and 400 mg M1,M2,M3,M4,M5
Orlistat Capsules 120 mg M1,M2,M3,M4,M5
Dosage:Tablets
Country: Canada
Format:eCTD
Product Name Modules
Acetaminophen and Tramadol Hydrochloride Tablets, 325mg+37.5mg M3
Almotriptan Tablets, 6.25mg, 12.5mg M3
Amlodipine Besilate Tablets, 5,10mg M1,M2,M3,M5
Amlodipine Besilate Tablets, 5 mg and 10 mg M3
Amlodipine Tablets 5 and 10 mg M3
Atorvastatin Tablets 10, 20, 40 and 80 mg M1,M2,M3,M5
Atovaquone and Proguanil Hydrochloride Tablets, 62.5/25 mg and 250/100 m M3
Bezafibrate SR Tablets 400 mg M1,M2,M3,M5
Bicalutamide Tablets 50 mg M3
Bisoprol Fumarate Tablets, 5, 10 mg M3
Bosentan Monohydrate Tablets, 62.5, 125 mg M3
Bosentan Tablets, 62.5, 125 mg M1,M2,M3,M5
Candesartan Cilexetil and Hydrochlorothiazide Tablets, 16/12.5 and 32/12.5m M3
Candesartan Cilexetil Tablets, 4,8,16,32 mg M1,M2,M3,M5
Ciprofloxacin Tablets USP, 250 mg, 500 mg, 750 mg M3
Citalopram Tablets 10 mg, 20 mg and 40 mg M1,M2,M3,M5
Cyclobenzaprine Hydrochloride Tablets USP 10 mg M1,M2,M3,M5
Desvenlafaxine Extended-Release Tablets 50 mg M1,M2,M3,M5
Digoxine Tablets 0.25, 0.125 and 0.0625 mg M1,M2,M3,M5
Donepezil HCl Tablets 5, 10 mg M1,M2,M3,M5
Donepezil HCl Tablets 5, 10 mg M1,M2,M3,M5
Doxazosin Mesylate Tablets USP, 1, 2 and 4 mg M1,M2,M3,M5
Doxylamine Succinate and Pyridoxine Hydrochloride Delayed Release Tablets, 10mg / 10m M3
Efaviernz Tablets USP 600 mg M1,M2,M3,M5
Efavirenz Tablets, 600 mg M3
Emtricitabine and Tenofovir Tablets, 200, 300 mg M1,M2,M3,M5
Emtricitabine and Tenofovir Tablets, 200, 300 mg M3
Enalapril Tablets, 2.5, 5, 10 and 20 mg M3
Entacapone Tablets, 200 mg M3
Entecavir Tablets 0.5 mg M1,M2,M3,M5
Ezetimibe Tablets USP- 10 mg M1,M2,M3,M5
Ezetimibe Tablets, 10 mg M3
Febuxostat Tablets 80 mg M1,M2,M3,M5
Fenofibrate Tablets, 40, 120 mg M3
Fenofibrate Tablets, 48, 145 mg M3
Fluconazole Tablets, 50, 100 mg M3
Frovatriptan Tablets 2.5 mg M1,M2,M3,M5
Gabapentin Tablets USP, 600, 800 mg M3
Gemfibrozil Tablets USP, 600 mg M3
Gliclizide Modified Release Tablets 30, 60 mg M1,M2,M3,M5
Hydroxychloroquine Sulfate Tablets USP 200 mg M1,M2,M3,M5
Irbesartan Tablets USP, 75 mg, 150 mg and 300 mg M3
Lacosamide Tablets 50, 100, 150, 200 mg M1,M2,M3
Lamivudine 150 mg and Zidovudine 300 mg Tablets M1,M2,M3,M5
Lamotrigine Tablets, 25 mg, 100 mg and 150 mg M3
Lisinopril and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, 20 mg/12.5 mg and 20 mg/25 m M3
Losartan Potassium and Hydrochlorothiazide Tablets, 50/12.5, 100/12.5, 100/25 m M3
Metoprolol Tartrate Tablets USP 25, 50 and 100mg M1,M2,M3,M5
Montelukast Sodium Chewable Tablets, 4, 5 mg M3
Montelukast Sodium 10 mg Tablets M1,M2,M3
Olanzapine Orally Disintegrating Tablets, 5, 10, 15, 20 mg M3
Olanzapine Tablets, 2.5, 5, 7.5, 10, 20 mg M3
Pantoprazole Magnesium Enteric Coated Tablets, 40mg M3
Perindopril Erbumine Tablets USP 2, 4, 8mg M1,M2,M3,M5
Pioglitazone Hydrochloride Tablets, 15 mg, 30 mg, 45 mg M3
Dosage:Capsules
Country: EU
Format:eCTD
Product Name Modules
Dabigatran Etexilate Capsules 75, 110, 150 mg M1,M2,M3,M5
Duloxetine DR Capsules, 30 and 60mg M1,M2,M3,M5
Fingolimod Capsules, 0.5 mg M1,M2,M3,M5
Gemfibrozil Capsules, USP, 300 mg M1,M2,M3,M5
Lansoprazole Delayed-Release Capsules, 15 mg and 30 mg M1,M2,M3,M5
Oseltamivir Phosphate Capsules, 30, 45, 75 mg M1,M2,M3,M5
Dosage:Tablets
Country: US
Format:eCTD
Product Name Modules
Acamprosate Calcium Delayed Release Tablets, 333 mg M3
Alprazolam Prolonged Release Tablets, 0.5 mg M3
razolam Prolonged Release Tablets, 1 mg M3
Alprazolam Prolonged Release Tablets, 2 mg M3
Amlodipine Besilate and Valsartan Tablets, 5/160, 10/160, 5/320, 10/32 M1,M2,M3,M5
Amlodipine Besylate and Olmesartan medoxomil Tablets, 5/20 and 10/40 m M3
Amlodipine Besylate and Valsartan Tablets, 5/160,5/320, 10/160 and 10/320 m M3
Apixaban Tablets, 2.5, 5 mg M1,M2,M3,M5
Armodafinil Tablets, 50/100/150/200/250 mg M3
Asenapine Sublingual Tablets, 5, 10 mg M1,M2,M3,M5
Baclofen Tablets USP, 10, 20 mg M3
Buprenorphine Hcl + Naloxone Hcl Sublingual Tablets, 8mg/2mg, 2mg/0.5mg M1,M2,M3,M5
Buspirone Hydrochloride Tablets USP,75, 100 mg M1,M2,M3,M5
Buspirone Hydrochloride Tablets, USP 5mg, 10 mg, 15 mg and 30 m M1,M2,M3,M5
Candesartan Cilexetil and Hydrochlorothiazide Tablets, 16/12.5 and 32/12.5m M3
Candesartan Cilexetil Tablets, 4,8,16,32 mg M3
Cinacalcet Hydrochloride Tablets, 30 mg, 60 mg, 90 mg M1,M2,M3,M5
Darifenacin Extended Release Tablets 7.5, 15 mg M1,M2,M3,M5
Darunavir Tablets, 75/150/300/400/600 mg M3
Desmopressin Acetate Tablets, 0.1/0.2 mg M3
Desvenlafaxine Extended-Release Tablets, 50, 100 mg M2,M3,M5
Didanosine Delayed Release Capsule, 125, 200, 250 & 400 mg M3
Donepezil HCl Tablets 5, 10 mg M1,M2,M3,M5
Donepezil HCl Tablets 23 mg M3
Donepezil HCl Tablets 5, 10 mg M3
Efavirenz Tablets, 600 mg M3
Entacapone Tablets, 200 mg M3
Entecavir Tablets, 0.5 and 1 mg M1,M3
Eprosartan Mesylate Tablets, 400 and 600mg M3
Ezetimibe and Simvastatin Tablets, 10/10, 10/20, 10/40, 10/80 m M1,M2,M3,M5
Ezetimibe Tablets, 10 mg M1,M3
Famciclovir Tablets, 125/250/500 mg M3
Famotidine Tablets USP, 20, 40 mg M1,M2,M3
Febuxostat Tablets, 40, 80 mg M1,M3
Flecainide Acetate Tablets, USP 50, 100 and 150 mg M1,M2,M3,M5
Fluoxetine Tablets USP, 10, 20 mg M1,M2,M3,M5
Fosamprenavir Calcium Tablets, 700 mg M3
Frovatriptan Succinate Tablets, 2.5 mg M3
Gabapentin Tablets USP, 600, 800 mg M3
Ibandronate Sodium Tablets, 150 mg M1,M3
Lamivudine and Zidovudine Tablets USP, 150 and 300 mg M3
Lamivudine Tablets, 100 mg M3
Lamotrigene Chewable Dispersible Tablets, 5, 25 mg M3
Lamotrigine Tablets USP, 25, 100, 150, 200 mg M2,M3,M5
Lansoprazole Delayed Release Orally Disintegrating Tablets,15, 30 mg M3
Lefunomide Tablets USP, 10, 20 mg M1,M2,M3,M4
Lisinopril Tablets USP, 2.5, 5, 10, 20, 30, 40 m M1,M3
Lithium Carbonate Extended Release Tablets USP, 300 mg M3
Lithium Carbonate Extended-Release Tablets USP, 300 mg M1,M2,M3,M5
Loratadine Tablets USP, 10 mg M3
Losartan Potassium and Hydrochlorothiazide Tablets, 50/12.5, 100/12.5 & 100/2 M1,M2,M3,M5
Losartan Potassium and Hydrochlorothiazide Tablets, 50/12.5, 100/12.5, 100/25 m M3
Meprobamate Tablets USP, 200, 400 mg M1,M2,M3
Mesalamine Delayed-Release Tablets, 1.2gm M1,M3
Metformin Hydrochloride Tablets USP, 500, 850 and 1000m M3
Metoprolol Succinate Extended Release Tablets USP, 25,50,100,200 mg M3
Metoprolol Tratarate & Hydrochlorothiazide Tablets, 50/25, 100/25, 100/50 m M1,M2,M3
Metronidazole Tablets USP, 250, 500 mg M1,M2,M3
Minocycline Hydrochloride Extended Release Tablets, 55, 80, 105 m M3
Minocycline Hydrochloride Extended Release Tablets, 65, 115 mg M3
Modafinil Tablets USP, 100, 200 mg M1,M2,M3,M5
Moxifloxacin Hydrochloride Tablets 400 mg M1,M2,M3,M5
Moxifloxacin Tablets, 400 mg M3
Nabumetone Tablets USP, 500 mg and 750 mg M3
Naratriptan HCl Tablets USP, 1, 2.5 mg M3
Nevirapine Tablets USP, 200 mg M3
Niacin Extended Release/ Simvastalin Tablets, 500/40 mg and 1000/40mg M3
Nisoldipine Extended-Release Tablets, 17, 25.5, 34 mg M1,M2,M3,M5
Nisoldipine Extended-Release Tablets, 8.5 mg M1,M2,M3,M5
Olanzapine Orally Disintegrating Tablets, 5, 10, 15, 20 mg M3
Olopatadine Ophthalmic solution USP 0.1 % M1,M2,M3
Pioglitazone Hydrochloride and Metformin Hydrochloride Extended Release Tablets, 15/1000 ,30/1000 m M3
Dosage:Capsules
Country: US
Format:eCTD
Product Name Modules
Amantadine Hydrochloride Capsules USP, 100 mg M1,M2,M3,M5
Budesonide Enteric Coated Capsules 3mg M1,M2,M3,M5
Dabigatran Etexilate Capsule 150 mg M1,M2,M3,M5
Esomeprazole Magnesium Delayed Release Capsules, 20, 40 mg M3
Fenofibric Acid DR Cap USP, 45, 135 mg M1,M2,M3,M5
Fingolimod Capsules, 0.5 mg M2,M3,M5
Itraconazole Capsules, 100 mg M1,M2,M3,M5
Itraconazole Capsules, 100 mg M3
Lansoprazole Delayed Release Capsules USP, 15mg M3
Mesalamine Delayed-Release Capsules, 400 mg M3
Metronidazole Capsule, 375 mg M1,M2,M3,M5
Dosage:Tablets
Country: USP/EP
Format:eCTD
Product Name Modules
Abacavir Sulfate Tablets, 300 mg M3
Abacavir Sulfate Tablets, 60 mg M3
Abacavir Sulfate+Lamivudine+Zidovudine Tablets, 300+150+300 mg M3
Efavirenz Tablets, 50/100/200 mg M3
Efavirenz, Emitricitaben and Tenofovir Tablets, 600/200/300m M3
Efavirenz, Lamivudine and Tenofovir Tablets, 600/300/300mg M3
Lamivudine, Nevirapine and Zidovudine Dispersible Tablets, 30,50,60 m M3
Dosage:Capsules
Country: USP/EP
Format:eCTD
Product Name Modules
Atazanavir Sulfate Capsules,150 mg and 300 mg M3
Dosage:Tablets
Country: EU
Format:eCTD
Product Name Modules
Amlodipine Tablets 5 and 10 mg M1,M2,M3,M4,M5
Amlodipine Valsartan Film Coated Tablets 5/80 mg, 5/160 mg, 10/160 mg M1,M2,M3,M4,M5
Anastrozole Tablets, 1mg M1,M2,M3,M4,M5
Aripiprazole Tablets 5 mg, 10 mg, 15 mg and 30 mg M1,M2,M3,M4,M5
Aripiprazole Tablets 5 mg, 10 mg, 15 mg and 30 mg M1,M2,M3,M4,M5
Atorvastatin Tablets 10 mg M1,M2,M3,M4,M5
Atorvastatin Tablets 20 mg M1,M2,M3,M4,M5
Atorvastatin Tablets 40 mg M1,M2,M3,M4,M5
Atorvastatin Tablets 80 mg M1,M2,M3,M4,M5
Betaxolol Hydrochloride Tablet, 20 mg M1,M2,M3,M4,M5
Bisoprol Fumarate Tablets, 5, 10 mg M1,M2,M3,M4,M5
Bosentan Tablets, 62.5, 125 mg M1,M2,M3,M4,M5
Bupropion Tablets USP (Modified Release), 150, 300 mg M1,M2,M3,M4,M5
Clarithromycin Prolonged Release Tablets, 500 mg M1,M2,M3,M4,M5
Desloratadine Tablets 5mg M1,M2,M3,M4,M5
Desogestrel and Ethinylestradiol Tablets 150 mcg, 20 mcg M1,M2,M3,M4,M5
Diclofenac Sodium and Misoprostol Tablets 50/0.2 & 75/0.2mg M1,M2,M3,M4,M5
Dienogest 2.0 mg/ Estradiol valerate 1.0 mg Tablets M1,M2,M3,M5
Drospirenone 3.0 mg/ Ethinylestradiol 0.020 mg Tablets M1,M2,M3,M5
Drospirenone 3.0 mg/ Ethinylestradiol 0.030 mg Tablets M1,M2,M3,M5
Erlotinib Tablets, 25, 150 and 100mg M1,M2,M3,M4,M5
Escitalopram Tablets, 5, 10, 15, and 20 mg M1,M2,M3,M4,M5
Etoricoxib Tablets, 30,60,90,120 mg M1,M2,M3,M4,M5
Etoricoxib Tablets, 30,60,90,120 mg M1,M2,M3,M4,M5
Everolimus Tablets, 2.5, 5, 10 mg M1,M2,M3,M4,M5
Exemestane Tablets 25 mg M1,M2,M3,M4,M5
Febuxostat Tablets, 60, 120 mg M1,M2,M3,M4,M5
Fexofenadine Hydrochloride Tablets, 120, 180 mg M1,M2,M3,M4,M5
Gefitinib Tablets 250 mg M1,M2,M3,M4,M5
Ibuprofen Tablets, 400 mg M1,M2,M3,M4,M5
Ibuprofen Tablets, 600 mg M1,M2,M3,M4,M5
Irbesartan & Hydrochlorothiazide 150mg/12.5mg, 300mg/12.5mg & 300mg/25mg Tablet M1,M2,M3,M4,M5
Irbesartan Tablets, 75 mg, 150 mg and 300 mg M1,M2,M3,M4,M5
Levodopa/Carbidopa/Entacapone Tablets, 50+12.5+200, 75/18.75/200, 100+25+200, 125/31.25/200, 150+37.5+200, 175/43.75/200, 200+50+200 m M1,M2,M3,M4,M5
Levonorgestrel 100 micrograms and Ethinylestradiol 20 micrograms Tablet M1,M2,M3,M4,M5
Linezolid Tablets, 600 mg M1,M2,M3,M4,M5
Memantine Hydrochloride Tablets 10, 20 mg M1,M2,M3,M4,M5
Nicorandil Tablets, 20, 10mg M1,M2,M3,M4,M5
Olmesartan & Hydrochlorothiazide Tablets, 20/12.5. 20/25, 40/12.5, 40/2 M1,M2,M3,M4,M5
Olmesartan Medoxomil Tablets, 10, 20, 40 mg M1,M2,M3,M4,M5
Oxycodone Hcl + Naloxone Hcl Prolonged Release Tablet, 5/2.5, 10/5, 20/10, 30/15, 40/20 mg M1,M2,M3,M4,M5
Dosage:Capsules
Country: EU
Format:eCTD
Modules:M1,M2,M3,M4,M5
Product Name
Alfacalcidol Soft Gelatin Capsules 0.25, 0.5, 1 mcg
Duloxetine HCl DR Capsules, 20, 40 mg
Duloxetine HCl DR Capsules, 30, 60 mg
Dutasteride Soft Gelatin Capsules 0.5 mg
Gabapentin Hard Gelatin Capsules 100, 300 and 400 mg
Orlistat Capsules 120 mg

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