Our LIST OF DOSSIER
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: 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: 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: 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 |