Products - US CTD Dossier List

US CTD Dossier List

Sr # Product Name Strengths Reference Product Dossier Availability
Central Nervous System
1 Aripiprazole Tablet 2/5/10/15/20/30 mg Abilify® Available
2 Carbidopa + Levodopa SR Tablet 25+100mg/50+200mg Sinemet SR® 16-Aug
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® 16-Jul
4 Desvenlafaxine ER Tablet 25/50/100mg Pristiq® 16-Sep
5 Donepezil Tablet 5/10 mg Aricept® Available
6 Donepezil OD Tablet 5/10 mg Aricept ODT® Available
7 Donepezil ER Tablet 23 mg Aricept® Available
8 Duloxetine ER Capsule 20/30/60 mg Cymbalta® Available
9 Escitalopram Oral Solution 5 mg/5ml Lexapro® Available
10 Escitalopram Tablet 5/10/20 mg Lexapro® Available
11 Eszopiclone Tablet 1/2/3 mg Lunesta® Available
12 Entacapone Tablet 200 mg Stalevo® Available
13 Lacosamide tablets 50/100/150/200mg Vimpat® Available
14 Memantine Tablet 5/10 mg Namenda® Available
15 Memantine Oral Solution 2mg/ml Namenda® Available
16 Memantine ER Capsule 7/14/21/28 mg Namenda XR® Available
17 Memantine ER + Donepezil Capsule 14mg+10mg/28mg+10mg Namzaric® Available
18 Milnacipran Tablet 12.5/25/50/100mg Savella® 16-Sep
19 Olanzapine Tablet 2.5/5/7.5/10/15/20 mg Zyprexa® Available
20 Olanzapine OD Tablet 5/10/15/20 mg Zyprexa Zydis® Available
21 Oxcarbazepine Suspension 300mg/5 ml Trileptal® Available
22 Paroxetine ER Tablet 12.5/25/37.5 mg Paxil-CR® 15-Dec
23 Pramipexole IR Tablet 0.125/0.25/0.5/1.0/1.5 mg Mirapex® Available
24 Pramipexole ER Tablet 0.375/0.75/1.5/2.25/3/3.75/4.5 mg Mirapex ER ® Available
25 Pregabalin Capsule 25/50/75/100/150/200/225/300 mg Lyrica® Available
26 Quetiapine IR Tablet 25/50/100/150/200/300/400 mg Seroquel® Available
27 Quetiapine SR Tablet 150/200/300/400 mg Seroquel XR® Available
28 Rasagiline Tablet 0.5/1 mg Azilect® 15-Nov
29 Rizatriptan Tablet 5/10 mg Maxalt® Available
30 Rizatriptan OD Tablet 5/10 mg Maxalt MLT® Available
31 Rivastigmine Capsule 1.5/3/4.5/6 mg Exelon® Available
32 Venlafaxine ER Capsule 37.5/75/150 mg Effexor SR® Available
33 Ziprasidone Capsule 20/40/60/80 mg Geodon® Available
34 Zolmitriptan Film Coated Tablet 2.5/5 mg Zomig® Available
35 Zolmitriptan OD Tablet 2.5/5 mg Zomig ZMT® Available
Anti-Diabetic
36 Metformin Tablet 500/850/1000 mg Glucophage® Available
37 Metformin + Pioglitazone Tablet 15+500/15+850 mg Actoplus MET® Available
38 Metformin ER Tablet 500/750 mg Glucophage XR® Available
39 Metformin ER + Pioglitazole Tablet 1000+15mg / 1000+ 30mg Actoplus MET XR® 16-Apr
40 Pioglitazone Tablet 15/30/45 mg Actos® Available
41 Repaglinide Tablet 0.5/1/2 mg Prandin® Available
42 Sitagliptin Tablet 25/50/100mg Januvia® 16-Jul
43 Sitagliptin + Metformin Tablet 1000+50mg Janomet® 16-Jul
Gastro Intestinal System
44 Esomeprazole Capsule 20/40 mg Nexium® Available
45 Lansoprazole capsules 15mg/30mg Prevacid® Available
46 Pantoprazole Sodium DR Tablet 20/40 mg Protonix® Available
47 Rabeprazole Enteric Coated Tablet 10/20 mg Aciphex® Available
Urinary System
48 Darifenacin ER Tablet 7.5/15 mg Enablex® Available
49 Solifenacin Tablet 5/10 mg Vesicare® Available
50 Tamsulosin Capsule 0.4 mg Flomax® Available
51 Trospium Tablet 20 mg Sanctura® Available
52 Tolterodine IR Tablet 1/2 mg Detrol® Available
53 Tolterodine ER Capsule 2 / 4mg Detrol LA® 16-May
Anti-Osteoporotic
54 Febuxostat Tablet 40/80 mg Uloric® Available
55 Ibandronate Tablet 150 mg Boniva® Available
56 Raloxifene Tablet 60 mg Evista® 16-Jan
57 Risedronate Tablet 5/30/35 mg Actonel® Available
Cardio Vascular System
58 Amlodipine Tablet 5/10 mg Norvasc® Available
59 Atorvastatin Tablet 10/20/40/80 mg Lipitor® Available
60 Candesartan Tablet 2/4/8/16/32 mg Atacand® Available
61 Candesartan + HCTZ Tablet 16+12.5/32+12.5/32+25 mg Atacand HCT® Available
62 Choline Fenofibrate Capsule 45/135 mg Trilipix® Available
63 Clopidogrel Tablet 75 mg Plavix® Available
64 Colesevelam Tablet 625 mg Welchol® Available
65 Fenofibrate Tablet 54/160 mg Triglide® 16-May
66 Irbesartan Tablet 75/150/300 mg Avapro® Available
67 Irbesartan + HCTZ Tablet 150+12.5/300+12.5/300+25 mg Avapro HCT® Available
68 Losartan Tablet 25/50/100 mg Cozaar® Available
69 Losartan + HCTZ Tablet 50+12.5/100+12.5/100+25 m g Hyzaar® Available
70 Metoprolol ER Tablet 25/50/100/200 mg Toprol XL® Available
71 Niacin ER Tablet 500/750/1000 mg Niaspan® Available
72 Olmesartan Tablet 5/10/20/40 mg Benicar® Available
73 Olmesartan + HCTZ Tablet 20+12.5/40+12.5/40+25 mg Benicar HCT® Available
74 Olmesartan + Amlodipine Tablet 20+5/20+10/40+5/40+10 mg Azor® Available
75 Olmesartan + Amlodipine + HCTZ Tablet 20+5+12.5/40+5+12.5/40+5+25/
40+10+12.5/40+10+25 mg
Tribenzor® Available
76 Prasugrel Tablet 5/10mg Effient® 16-Aug
77 Rosuvastatin Tablet 5/10/20/40 mg Crestor® Available
78 Telmisartan Tablet 20/40/80 mg Micardis® Available
79 Telmisartan + HCTZ Tablet 12.5+40/12.5+80/25+80 mg Micardis HCT® Available
80 Valsartan Tablet 40/80/160/320 mg Diovan® Available
81 Valsartan + HCTZ Tablet 80+12.5/160+12.5/160+25/320+12.5/320+25 mg Diovan HCT® Available
82 Valsartan + Amlodipine Tablet 5+160/5+320/10+160/10+320 mg Exforge® Available
83 Valsartan + Amlodipine + HCTZ Tablet 5+160+12.5/10+160+12.5/5+160+25/
10+160+25/10+320+25 mg
Exforge HCT® Available
84 Warfarin Tablet 1/2/2.5/3/4/5/6/7.5/10 mg Coumadin® Available
Erectile Dysfunction
85 Sildenafil Citrate Tablet 20/25/50/100 mg Viagra® Available
86 Tadalafil Tablet 2.5/5/10/20 mg Cialis® Available
87 Vardenafil IR Tablet 2.5/5/10/20 mg Levitra® Available
88 Vardenafil ODT Tablet 10 mg Staxyn® Available
Analgesics
89 Celecoxib Capsule 50/100/200/400 mg Celebrex® Available
90 Tramadol Tablet 50/100/200/300 mg Ultram® Available
91 Tramadol ER Tablet 100/200/300 mg Ultram ER® 16-Jan
92 Tramadol + Acetaminophen Tablet 37.5+325 mg Ultracet® Available
Miscellaneous
93 Cevimeline Capsule 30 mg Evoxac® Available
94 Cholestyramine Sachet 4gm   Available
95 Cinacalcet Tablet 30/60/90 mg Sensipar® 16-Apr
96 Cyclobenzaprine ER Capsule 15/30 mg Amrix® Available
97 Doxycycline Capsules 40mg Oracea® 16-May
98 Levofloxacin Tablet 250/500/750 mg Levaquin® Available
99 Levofloxacin Oral Solution 25 mg/ml Levaquin® Available
100 Levocetirizine Tablet 5 mg Xyzal® Available
101 Montelukast Chewable Tablet 4/5 mg Singlulair® Available
102 Montelukast Tablet 10 mg Singulair® Available
103 Moxifloxacin Granules 400mg Avalox® 16-Jan
104 Nitrofurantoin Capsule 25/50/100 mg Macrodantin® Available
105 Propylthiouracil Tablet 50mg Propylthiouracil® 15-Nov
106 Sevelamer HCL Tablet 400/800 mg Renagel® Available
107 Sevelamer Carbonate Tablet 800 mg Renvela® Available
108 Sevelamer Carbonate Suspension 800/2.4 mg/ packet Renvela® Available
109 Famciclovir Tablet 125/250/500 mg Famvir® Available
110 Oseltamivir Capsule 30/45/75 mg Tamiflu® Available

Disclaimer: "The information contained here shall not constitute an offer to sell or sale in the territories where product is under patent protection."