|
Approval Date |
Reference Listed Drug |
Generic Drug Name |
NDA Holder |
ANDA Applicant |
|
10/9/2013 |
Levonorgestrel / Ethinyl Estradiol |
Levonorgestrel / Ethinyl Estradiol |
Watson Labs |
Famy Care |
|
10/9/2013 |
Vancomycin Hydrochloride |
Vancomycin Hydrochloride |
Fresenius Kabi USA |
Emcure Pharms |
|
10/9/2013 |
Tindamax |
Tinidazole |
Mission Pharma |
Unique Pharm Labs |
|
10/10/2013 |
Tobi |
Tobramycin |
Novartis Pharms |
Teva |
|
10/10/2013 |
Geodon |
Ziprasidone Hydrochloride |
Pfizer |
Mylan |
|
10/11/2013 |
Penicillin V Potassium |
Penicillin V Potassium |
Sandoz |
Hikma Pharms |
|
10/11/2013 |
Wellbutrin SR |
Bupropion Hydrochloride |
GlaxoSmithKline |
Jubilant Life |
|
10/11/2013 |
Zyban |
Bupropion Hydrochloride |
GlaxoSmithKline |
Jubilant Life |
|
10/11/2013 |
Acyclovir Sodium |
Acyclovir Sodium |
Fresenius Kabi USA |
Aurobindo Pharma |
|
10/15/2013 |
Prochlorperazine Edisylate |
Prochlorperazine Edisylate |
Hikma Maple |
Emcure Pharms |
|
10/17/2013 |
Precose |
Acarbose |
Bayer Healthcare |
Virtus Pharm |
|
10/17/2013 |
Lamictal HR |
Lamotrigine |
GlaxoSmithKline |
Actavis Elizabeth |
|
10/21/2013 |
Norvasc |
Amlodipine Besylate |
Pfizer |
Unichem Labs |
|
10/28/2013 |
Solaraze |
Diclofenac Sodium |
Fougera Pharms |
Tolmar |
|
10/29/2013 |
Duraclon |
Clonidine Hydrochloride |
Mylan |
Exela Pharma SCS |
|
10/29/2013 |
Zestril |
Lusinopril |
Astrazeneca |
Invagen Pharms |
|
10/29/2013 |
Zovirax |
Acyclovir Sodium |
GlaxoSmithKline |
Hetero Labs |
|
10/31/2013 |
Detrol LA |
Tolterodine Tartrate |
Mylan |
Mylan |
|
10/31/2013 |
Vancomycin Hydrochloride |
Vancomycin Hydrochloride |
Fresenius Kabi USA/Hospira |
Emcure Pharms |
|
10/31/2013 |
Vancomycin Hydrochloride |
Vancomycin Hydrochloride |
Fresenius Kabi USA/Hospira |
Emcure Pharms |
|
11/5/2013 |
Propecia |
Finasteride |
Merck |
Teva |
|
11/5/2013 |
Propecia |
Finasteride |
Merck |
Mylan |
|
11/5/2013 |
Propecia |
Finasteride |
Merck |
Actavis Totowa |
|
11/5/2013 |
Propecia |
Finasteride |
Merck |
Accord Healthcare |
|
11/5/2013 |
Propecia |
Finasteride |
Merck |
Aurobindo Pharma |
|
11/5/2013 |
Marcaine Hydrochloride / Marcaine Hydrochloride Preservative Free |
Bupivacaine Hydrochloride Preservative Free |
Hospira |
Aurobindo Pharma |
|
11/6/2013 |
Loestrin |
Norethindrone Acetate / Ethinyl Estradiol |
Warner Chilcott |
Famy Care |
|
11/6/2013 |
Lopressor HCT |
Metoprolol Tartrate / Hydrochlorothiazide |
US Pharms |
Alembic Pharms |
|
11/8/2013 |
Aciphex |
Rabeprazole Sodium |
Eisai |
Teva |
|
11/8/2013 |
Aciphex |
Rabeprazole Sodium |
Eisai |
Dr Reddy's Labs |
|
11/8/2013 |
Aciphex |
Rabeprazole Sodium |
Eisai |
Mylan |
|
11/8/2013 |
Aciphex |
Rabeprazole Sodium |
Eisai |
Lupin |
|
11/8/2013 |
Aciphex |
Rabeprazole Sodium |
Eisai |
Kremers Urban |
|
11/8/2013 |
Terbutaline Sulfate |
Terbutaline Sulfate |
Bedford |
United Biomedical |
|
11/8/2013 |
Felodipine |
Felodipine |
Mylan |
Heritage Pharms |
|
11/8/2013 |
Aciphex |
Rabeprazole Sodium |
Eisai |
Torrent Pharms |
|
11/12/2013 |
Octreotide Acetate (Preservative Free) / Sandostatin |
Octreotide Acetate (Preservative Free) |
Bedford/Novartis |
Sagent Pharms |
|
11/12/2013 |
Octreotide Acetate / Sandostatin |
Octreotide Acetate |
Bedford/Novartis |
Sagent Pharms |
|
11/12/2013 |
Methylin |
Methylphenidate Hydrochloride |
Mallinckrodt |
Caraco |
|
11/13/2013 |
Lamictal XR |
Lamotrigine |
GlaxoSmithKline |
Actavis Elizabeth |
|
11/14/2013 |
Loestrin |
Norethindrone Acetate / Ethinyl Estradiol |
Warner Chilcott |
Famy Care |
|
11/15/2013 |
Zovirax |
Acyclovir |
GlaxoSmithKline |
Cadila Pharms |
|
11/18/2013 |
Focalin XR |
Dexmethylphenidate Hydrochloride |
Novartis |
Intellipharmaceutics |
|
11/18/2013 |
Luvox CR |
Fluvoxamine Maleate |
Jazz Pharms |
Actavis Elizabeth |
|
11/18/2013 |
Campral |
Acamprosate Calcium |
Forest Labs |
Barr Labs Div Teva |
|
11/19/2013 |
Focalin XR |
Dexmethylphenidate Hydrochloride |
Novartis |
Teva |
|
11/19/2013 |
Focalin XR |
Dexmethylphenidate Hydrochloride |
Novartis |
Teva |
|
11/21/2013 |
Focalin XR |
Dexmethylphenidate Hydrochloride |
Novartis |
Watson Labs |
|
11/21/2013 |
Prandin |
Repaglinide |
Novo Nordisk |
Sandoz |
|
11/22/2013 |
Levaquin |
Levofloxacin |
Janssen Pharms |
Watson Labs |
|
11/25/2013 |
Topamax |
Torpiramate |
Janssen Pharms |
Hikma Pharms |
|
11/25/2013 |
Amiodarone Hydrchloride |
Amiodarone Hydrochloride |
Akorn/Fresenius Kabi USA/Gland Pharma/Hospira/Mylan |
Hospira |
|
11/25/2013 |
Amiodarone Hydrchloride |
Amiodarone Hydrochloride |
Akorn/Fresenius Kabi USA/Gland Pharma/Hospira/Mylan |
Hospira |
|
11/26/2013 |
Seroquel |
Quetiapine Fumarate |
Astrazeneca |
Jubilant Life |
|
11/26/2013 |
Maxalt |
Rizatriptan Benzoate |
Merck |
Emcure Pharms |
|
11/26/2013 |
Retrovir |
Zidovudine |
VIIV Healthcare |
Liaoning Chengda |
|
11/27/2013 |
Ketorolac Tromethamine |
Ketorolac Tromethamine |
Bedford |
Sagent Pharms |
|
11/27/2013 |
Trazodone Hydrochloride |
Trazodone Hydrochloride |
Apotex |
Torrent Pharms |
|
11/27/2013 |
Dextroamp Saccharate / AMP Aspartate / Dextroamp Sulfate / AMP Sulfate |
Dextroamp Saccharate / AMP Aspartate / Dextroamp Sulfate / AMP Sulfate |
Barr |
Aurolife Pharma |
|
11/29/2013 |
Caduet |
Amlodipine Besylate / Atorvastatin Calcium |
Pfizer |
Mylan |
|
12/2/2013 |
Amoxicillin / Clavulanate Potassium |
Amoxicillin / Clavulanate Potassium |
Teva |
Wockhardt |
|
12/2/2013 |
Cabergoline |
Cabergoline |
Par Pharms |
Mylan |
|
12/4/2013 |
Trusopt |
Dorzolamide Hydrochloride |
Merck |
Zach Systems |
|
12/4/2013 |
Cosopt |
Dorzolamide Hydrochloride / Timolol Maleate |
Oak Pharms Akorn |
Zach Systems |
|
12/4/2013 |
Loestrin 21 |
Ethinyl Estradiol / Norethindrone acetate |
Warner Chilcott |
Novast Labs |
|
12/5/2013 |
Trizivir |
Abacavir Sulfate / Lamivudine / Zidovudine |
VIIV Healthcare |
Lupin |
|
12/9/2013 |
Indomethacin |
Indomethacin |
Sandoz |
Watson Labs |
|
12/9/2013 |
Ammonia N 13 |
Ammonia N 13 |
Feinstein |
Kreitchman Pet Ctr |
|
12/11/2013 |
Cymbalta |
Duloxetine Hydrochloride |
Lilly |
Lupin |
|
12/11/2013 |
Cymbalta |
Duloxetine Hydrochloride |
Lilly |
Dr Reddy's Labs |
|
12/11/2013 |
Cymbalta |
Duloxetine Hydrochloride |
Lilly |
Sun Pharma Global |
|
12/11/2013 |
Cymbalta |
Duloxetine Hydrochloride |
Lilly |
Torrent Pharms |
|
12/11/2013 |
Cymbalta |
Duloxetine Hydrochloride |
Lilly |
Aurobindo Pharma |
|
12/11/2013 |
Cymbalta |
Duloxetine Hydrochloride |
Lilly |
Teva |
|
12/12/2013 |
Amikacin Sulfate |
Amikacin Sulfate |
Bedford |
Emcure Pharms |
|
12/13/2013 |
Xopenex |
Levalbuterol Hydrochloride |
Sunovion |
Cipla |
|
12/13/2013 |
Felodipine |
Felodipine |
Mylan |
Ranbaxy Labs |
|
12/13/2013 |
Bacitracin |
Bacitracin |
Perrigo |
Akorn |
|
12/17/2013 |
Cymbalta |
Duloxetine Hydrochloride |
Lilly |
Actavis Elizabeth |
|
12/20/2013 |
Totacillin N |
Ampicillin Sodium |
GlaxoSmithKline |
Istituto Bio Ita Spa |
|
12/20/2013 |
Reglan |
Metoclopramide |
Baxter Healthcare |
Emcure Pharms |
|
12/23/2013 |
DDAVP |
Desmopressin Acetate |
Sanofi Aventis |
Sun Pharma Global |
|
12/23/2013 |
Sodium Fluoride F 18 |
Sodium Fluoride F-18 |
NIH NCI DCTD |
Univ TX MD Anderson |
|
12/23/2013 |
Lamictal XR |
Lamotrigine |
GlaxoSmithKline |
Torrent Pharms |
|
12/23/2013 |
Fludeoxyglucose F18 |
Fludeoxyglucose F-18 |
Feinstein |
WI Medcl Cyclotron |
|
12/26/2013 |
Percocet |
Oxycodone / Acetaminophen |
Vintage Parms |
Caraco |
|
12/26/2013 |
Patossium Chloride |
Potasium Chloride |
Watson Labs |
Anchen Pharms |
|
12/30/2013 |
Lotrel |
Amiodipine Besylate / Benazepril Hydrochloride |
Novartis |
Apotex |
