Reference Listed Drug |
NDA Holder |
Generic Drug Name |
ANDA Applicant(s) |
Indication |
Launch Date |
Avapro |
Sanofi Aventis |
Irbesartan |
Teva |
High blood pressure treatment |
Apr. 2, 2012 |
Avalide |
Sanofi Aventis |
Irbesartan-hydrochlorothiazide |
Teva |
High blood pressure treatment |
Apr. 2, 2012 |
Sular Extended Release |
Shionogi |
Nisoldipine extended release tablets |
Prasco |
Treatment of high blood pressure |
Apr. 2, 2012 |
Mesnex Injection |
Baxter Healthcare |
Mesna injection |
Mylan |
Prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis |
Apr. 3, 2012 |
Provigil |
Cephalon/Teva |
Modafinil tablets |
Par Pharmaceutical |
Wakefulness-promoting agent |
Apr. 6, 2012 |
Vancocin HCl Capsules |
ViroPharma |
Vancomycin hydrochloride |
Watson Pharmaceuticals |
Treatment of C. difficile-associated diarrhea and enterocolitis |
Apr. 10, 2012 |
Vancocin HCl Capsules |
ViroPharma |
Vancomycin hydrochloride |
Akorn |
Treatment of C. difficile-associated diarrhea and enterocolitis |
Apr. 10, 2012 |
Vancocin HCl Capsules |
ViroPharma |
Vancomycin hydrochloride |
Prasco |
Treatment of C. difficile-associated diarrhea and enterocolitis |
Apr. 11, 2012 |
Mucinex |
Adams Respiratory Therapeutics |
Guaifenesin extended-release tablets |
Perrigo |
Relieve chest congestion and make coughs more productive |
Apr. 12, 2012 |
Lescol Capsules |
Novartis |
Fluvastatin capsules |
Mylan |
Familial and nonfamilial hypercholesterolemia and mixed dyslipidemia |
Apr. 13, 2012 |
Fortamet |
Shionogi |
Metformin hydrochloride extended-release tablets |
Watson Pharmaceuticals |
Adjunct to diet and exercise to lower blood glucose |
Apr. 19, 2012 |
Zyprexa Tablets |
Eli Lilly and Company |
Olanzapine |
Mylan |
Treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar 1 disorder and maintenance treatment of bipolar 1 disorder |
Apr. 24, 2012 |
Stalevo |
Orion Corporation/Novartis |
Levodopa, carbidopa and entacapone |
Wockhardt |
Treatment of Parkinson's disease |
Apr. 24, 2012 |
Doryx |
Mayne Pharmaceutical |
Dolycycline hyclate delayed-release tablets |
Mylan |
Antimicrobial |
Apr. 30, 2012 |
Plavix |
Sanofi Aventis |
Clopidogrel tablets |
Mylan |
Acute coronary syndrome and recent myocardial infarction, stroke or established peripheral arterial disease |
May. 17, 2012 |
Prevacide 24HR Capsules |
Novartis |
Lansoprazole |
Perrigo |
Treatment of frequent heartburn |
May. 18, 2012 |
Requip XL |
GlaxoSmithKline |
Ropinirole extended-release tablets. |
Actavis |
Treatment for Parkinson's disease |
May. 18, 2012 |
Viramune Tablets |
Boehringer Ingelheim |
Nevirapine tablets. |
Mylan |
Combination antiretroviral treatment of HIV-1 infection |
May. 23, 2012 |
Lipitor |
Pfizer |
Atorvastatin calcium tablets |
Mylan |
Treatment of hypercholesterolemia and mixed dyslipidemia |
May. 29, 2012 |
Adalat CC |
Bayer |
Nifedipine extended-release tablets |
Actavis |
Treatment of hypertension |
May. 30, 2013 |
Requip XL |
GlaxoSmithKline |
Ropinirole hydrochloride XR |
Dr. Reddy's Laboratories |
Treatment for Parkinson's disease |
Jun. 7 2012 |
Exelon |
Novartis |
Rivastigmine tartrate Capsules |
Breckenridge Pharmaceutical |
Treatment of mild to moderate dementia of the Alzheimer's type, and for the treatment of mild to moderate dementia associated with Parkinson's disease |
Jun. 14 2012 |
Exelon |
Novartis |
Rivastigmine tartrate capsules |
Alembic Pharmaceuticals |
Treatment of mild to moderate dementia of the Alzheimer's type, and for the treatment of mild to moderate dementia associated with Parkinson's disease |
Jun. 14 2012 |
Symbyax |
Lilly USA |
Olanzapine/fluoxetine |
Teva |
Treatment-resistant depression and bipolar I depression |
Jun. 21, 2012 |
Duac Gel |
Stiefel Laboratories |
Clindamycin phosphate and benzoyl peroxide 1.2%/5% topical gel |
Perrigo |
Topical treatment of inflammatory acne vulgaris |
Jun. 27 2012 |
Thiamine Hydrochloride |
|
Thiamine hydrochloride |
Mylan |
Thiamine deficiency |
Jun. 28 2012 |
Boniva |
Roche |
Ibandronate |
Dr. Reddy's Laboratories |
Treatment of osteoporosis in women after menopause |
Jun. 29 2012 |