Products - US CTD Dossier List

US CTD Dossier List

Sr # Product Name Strengths Reference Product Therapeutic Class
Central Nervous System
1 Aripiprazole Tablet 2/5/10/15/20/30 mg Abilify® Anti-psychotic (Schizophrenia)
2 Carbidopa + Levodopa SR Tablet 25+100mg/50+200mg Sinemet SR®
3 Carbidopa+Levodopa+ Entacapone Tablet 12.5+50+200mg/18.75+75+200mg/
25+100+200mg/31.25+125+200mg
/37.5+150+200mg/43.75+175+200mg/
50+200+200mg
Stalevo®
4 Desvenlafaxine ER Tablet 25/50/100mg Pristiq®
5 Donepezil Tablet 5/10 mg Aricept® Anti-psychotic (Alzheimer)
6 Donepezil OD Tablet 5/10 mg Aricept ODT® Anti-psychotic (Alzheimer)
7 Donepezil ER Tablet 23 mg Aricept® Anti-psychotic (Alzheimer)
8 Duloxetine ER Capsule 20/30/60 mg Cymbalta® Anti-depressant
9 Escitalopram Oral Solution 5 mg/5ml Lexapro® Anti-depressant
10 Escitalopram Tablet 5/10/20 mg Lexapro® Anti-depressant
11 Eszopiclone Tablet 1/2/3 mg Lunesta® Insomnia
12 Entacapone Tablet 200 mg Stalevo® Anti-parkinson
13 Lacosamide tablets 50/100/150/200mg Vimpat® Aniti siezure
14 Memantine Tablet 5/10 mg Namenda® Anti-psychotic (Alzheimer)
15 Memantine Oral Solution 2mg/ml Namenda® Anti-psychotic (Alzheimer)
16 Memantine ER Capsule 7/14/21/28 mg Namenda XR® Anti-psychotic (Alzheimer)
17 Memantine ER + Donepezil Capsule 14mg+10mg/28mg+10mg Namzaric® Anti-psychotic (Alzheimer)
18 Milnacipran Tablet 12.5/25/50/100mg Savella®
19 Olanzapine Tablet 2.5/5/7.5/10/15/20 mg Zyprexa® Anti-psychotic (Schizophrenia)
20 Olanzapine OD Tablet 5/10/15/20 mg Zyprexa Zydis® Anti-psychotic (Schizophrenia)
21 Oxcarbazepine Suspension 300mg/5 ml Trileptal® Anti-epileptic
22 Paroxetine ER Tablet 12.5/25/37.5 mg Paxil-CR® Anti-depressant
23 Pramipexole IR Tablet 0.125/0.25/0.5/1.0/1.5 mg Mirapex® Anti-parkinson
24 Pramipexole ER Tablet 0.375/0.75/1.5/2.25/3/3.75/4.5 mg Mirapex ER ® Anti-parkinson
25 Pregabalin Capsule 25/50/75/100/150/200/225/300 mg Lyrica® Anti-epileptic
26 Quetiapine IR Tablet 25/50/100/150/200/300/400 mg Seroquel® Anti-psychotic (Schizophrenia)
27 Quetiapine SR Tablet 150/200/300/400 mg Seroquel XR® Anti-psychotic (Schizophrenia)
28 Rasagiline Tablet 0.5/1 mg Azilect® Anti-parkinson
29 Rizatriptan Tablet 5/10 mg Maxalt® Migraine
30 Rizatriptan OD Tablet 5/10 mg Maxalt MLT® Migraine
31 Rivastigmine Capsule 1.5/3/4.5/6 mg Exelon® Anti-psychotic (Alzheimer)
32 Venlafaxine ER Capsule 37.5/75/150 mg Effexor SR® Anti-depressant
33 Ziprasidone Capsule 20/40/60/80 mg Geodon® Anti-psychotic (Schizophrenia)
34 Zolmitriptan Film Coated Tablet 2.5/5 mg Zomig® Migraine
35 Zolmitriptan OD Tablet 2.5/5 mg Zomig ZMT® Migraine
Anti-Diabetic
1 Metformin Tablet 500/850/1000 mg Glucophage® Anti-diabetic
2 Metformin + Pioglitazone Tablet 15+500/15+850 mg Actoplus MET® Anti-diabetic
3 Metformin ER Tablet 500/750 mg Glucophage XR® Anti-diabetic
4 Metformin ER + Pioglitazole Tablet 1000+15mg / 1000+ 30mg Actoplus MET XR® Anti-diabetic
5 Pioglitazone Tablet 15/30/45 mg Actos® Anti-diabetic
6 Repaglinide Tablet 0.5/1/2 mg Prandin® Anti-diabetic
7 Sitagliptin Tablet 25/50/100mg Januvia®
8 Sitagliptin + Metformin Tablet 1000+50mg Janomet®
Gastro Intestinal System
1 Esomeprazole Capsule 20/40 mg Nexium® Proton Pump Inhibitor
2 Lansoprazole capsules 15mg/30mg Prevacid® Proton Pump Inhibitor
3 Pantoprazole Sodium DR Tablet 20/40 mg Protonix® Proton Pump Inhibitor
4 Rabeprazole Enteric Coated Tablet 10/20 mg Aciphex® Proton Pump Inhibitor
Urinary System
1 Darifenacin ER Tablet 7.5/15 mg Enablex® Overactive bladder
2 Solifenacin Tablet 5/10 mg Vesicare® Overactive bladder
3 Tamsulosin Capsule 0.4 mg Flomax® Benign prostatic hyperplasia
4 Trospium Tablet 20 mg Sanctura® Overactive bladder
5 Tolterodine IR Tablet 1/2 mg Detrol® Anti-spasmodics
6 Tolterodine ER Capsule 2 / 4mg Detrol LA® Anti-spasmodics
Anti-Osteoporotic
1 Febuxostat Tablet 40/80 mg Uloric® Anti-gout
2 Ibandronate Tablet 150 mg Boniva® Anti-osteoporotic
3 Raloxifene Tablet 60 mg Evista® Anti-osteoporotic
4 Risedronate Tablet 5/30/35 mg Actonel® Anti-osteoporotic
Cardio Vascular System
1 Amlodipine Tablet 5/10 mg Norvasc® Anti-hypertensive
2 Atorvastatin Tablet 10/20/40/80 mg Lipitor® Anti-hyperlipidemic
3 Candesartan Tablet 2/4/8/16/32 mg Atacand® Anti-hypertensive
4 Candesartan + HCTZ Tablet 16+12.5/32+12.5/32+25 mg Atacand HCT® Anti-hypertensive
5 Choline Fenofibrate Capsule 45/135 mg Trilipix® Anti-hyperlipidemic
6 Clopidogrel Tablet 75 mg Plavix® Anti-platelet
7 Colesevelam Tablet 625 mg Welchol® Anti-hyperlipidemic
8 Fenofibrate Tablet 54/160 mg Triglide® Anti-hyperlipidemic
9 Irbesartan Tablet 75/150/300 mg Avapro® Anti-hypertensive
10 Irbesartan + HCTZ Tablet 150+12.5/300+12.5/300+25 mg Avapro HCT® Anti-hypertensive
11 Losartan Tablet 25/50/100 mg Cozaar® Anti-hypertensive
12 Losartan + HCTZ Tablet 50+12.5/100+12.5/100+25 m g Hyzaar® Anti-hypertensive
13 Metoprolol ER Tablet 25/50/100/200 mg Toprol XL® Anti-hypertensive
14 Niacin ER Tablet 500/750/1000 mg Niaspan® Vitamin B3
15 Olmesartan Tablet 5/10/20/40 mg Benicar® Anti-hypertensive
16 Olmesartan + HCTZ Tablet 20+12.5/40+12.5/40+25 mg Benicar HCT® Anti-hypertensive
17 Olmesartan + Amlodipine Tablet 20+5/20+10/40+5/40+10 mg Azor® Anti-hypertensive
18 Olmesartan + Amlodipine + HCTZ Tablet 20+5+12.5/40+5+12.5/40+5+25/
40+10+12.5/40+10+25 mg
Tribenzor® Anti-hypertensive
19 Prasugrel Tablet 5/10mg Effient®
20 Rosuvastatin Tablet 5/10/20/40 mg Crestor® Anti-hyperlipidemic
21 Telmisartan Tablet 20/40/80 mg Micardis® Anti-hypertensive
22 Telmisartan + HCTZ Tablet 12.5+40/12.5+80/25+80 mg Micardis HCT® Anti-hypertensive
23 Valsartan Tablet 40/80/160/320 mg Diovan® Anti-hypertensive
24 Valsartan + HCTZ Tablet 80+12.5/160+12.5/160+25/320+12.5/320+25 mg Diovan HCT® Anti-hypertensive
25 Valsartan + Amlodipine Tablet 5+160/5+320/10+160/10+320 mg Exforge® Anti-hypertensive
26 Valsartan + Amlodipine + HCTZ Tablet 5+160+12.5/10+160+12.5/5+160+25/
10+160+25/10+320+25 mg
Exforge HCT® Anti-hypertensive
27 Warfarin Tablet 1/2/2.5/3/4/5/6/7.5/10 mg Coumadin® Anti-coagulant
Erectile Dysfunction
1 Sildenafil Citrate Tablet 20/25/50/100 mg Viagra® Erectile dysfunction
2 Tadalafil Tablet 2.5/5/10/20 mg Cialis® Erectile dysfunction
3 Vardenafil IR Tablet 2.5/5/10/20 mg Levitra® Erectile dysfunction
4 Vardenafil ODT Tablet 10 mg Staxyn® Erectile dysfunction
Analgesics
1 Celecoxib Capsule 50/100/200/400 mg Celebrex® NSAID (Pain/Infalmmation)
2 Tramadol Tablet 50/100/200/300 mg Ultram® Opioid analgesics
3 Tramadol ER Tablet 100/200/300 mg Ultram ER® Opioid analgesics
4 Tramadol + Acetaminophen Tablet 37.5+325 mg Ultracet® Opioid analgesics
Miscellaneous
1 Cevimeline Capsule 30 mg Evoxac® Sjogren's Syndrome (Dry Mouth)
2 Cholestyramine Sachet 4gm   Hypercholesterolemia
3 Cinacalcet Tablet 30/60/90 mg Sensipar® Hyperparathyroidism
4 Cyclobenzaprine ER Capsule 15/30 mg Amrix® Skeletal muscle relaxant
5 Doxycycline Capsules 40mg Oracea® Anti-bacterial
6 Levofloxacin Tablet 250/500/750 mg Levaquin® Anti-bacterial
7 Levofloxacin Oral Solution 25 mg/ml Levaquin® Anti-bacterial
8 Levocetirizine Tablet 5 mg Xyzal® Anti-allergic
9 Montelukast Chewable Tablet 4/5 mg Singlulair® Anti-asthama
10 Montelukast Tablet 10 mg Singulair® Anti-asthma
11 Moxifloxacin Granules 400mg Avalox® Anti-bacterial
12 Nitrofurantoin Capsule 25/50/100 mg Macrodantin® Anti-biotic (Urinary tract infections)
13 Propylthiouracil Tablet 50mg Propylthiouracil® Hyperthyroidism
14 Sevelamer HCL Tablet 400/800 mg Renagel® Hyperphosphatemia
15 Sevelamer Carbonate Tablet 800 mg Renvela® Hyperphosphatemia
16 Sevelamer Carbonate Suspension 800/2.4 mg/ packet Renvela® Hyperphosphatemia
17 Famciclovir Tablet 125/250/500 mg Famvir® Anti-retro viral (Herpes Zoster virus)
18 Oseltamivir Capsule 30/45/75 mg Tamiflu® Anti-retro viral (Anti-Influenza)

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