| Approval Date | Reference Listed Drug | Generic Drug Name | NDA Holder | ANDA Applicant |
|---|---|---|---|---|
|
4/1/2014 |
Lasix |
Furosemide |
Sanofi Aventis US |
Caraco |
|
4/2/2014 |
Kapvay |
Clonidine Hydrochloride |
Concordia Pharms |
Anchen Pharms |
|
4/2/2014 |
Entocort EC |
Budesonide |
AstraZeneca |
Barr Labs Div Teva |
|
4/2/2014 |
Vesicare |
Solifenacin Succinate |
Astellas |
Teva |
|
4/3/2014 |
Viramune XR |
Nevirapine |
Boehringer Ingelheim |
Apotex |
|
4/3/2014 |
Viramune XR |
Nevirapine |
Boehringer Ingelheim |
Sandoz |
|
4/3/2014 |
Avelox |
Moxifloxacin Hydrochloride |
Bayer Healthcare |
Torrent Pharms |
|
4/3/2014 |
Procardia XL |
Nifedipine |
Pfizer |
TWi Pharms |
|
4/4/2014 |
Valtrex |
Valacyclovir Hydrochloride |
GlaxoSmithKline |
Apotex |
|
4/7/2014 |
Nafcillin Sodium |
Nafcillin Sodium |
Sandoz |
Agila Specialties |
|
4/7/2014 |
Unasyn |
Ampicillin / Sulbactam |
Pfizer |
Agila Specialties |
|
4/7/2014 |
Unasyn |
Ampicillin / Sulbactam |
Pfizer |
Agila Specialties |
|
4/7/2014 |
Ampicillin Sodium |
Ampicillin Sodium |
Sandoz |
Agila Specialties |
|
4/7/2014 |
Ultracet |
Tramadol Hydrochloride / Acetaminophen |
Janssen Pharms |
Apotex |
|
4/7/2014 |
Microzide |
Hydrochlorothiazide |
Watson Labs |
Caraco |
|
4/7/2014 |
Actos |
Pioglitazone Hydrochloride |
Takeda Pharms USA |
Lupin |
|
4/7/2014 |
Lovaza |
Omega-3-Acid Ethyl Esters |
SmithKline Beecham |
Teva |
|
4/7/2014 |
Nimodipine |
Nimodipine |
Banner Pharmacaps |
ThePharmaNetwork |
|
4/8/2014 |
Eloxatin / Oxaliplatin |
Oxaliplatin |
Sanofi Aventis US/Teva |
Sun Pharma Global |
|
4/9/2014 |
Zomig |
Zolmitriptan |
IPR |
Invagen Pharms |
|
4/9/2014 |
Ampicillin Sodium |
Ampicillin Sodium |
Sandoz |
Strides Arcolab |
|
4/11/2014 |
Xylocaine / Xylocaine Preservative Free |
Lidocaine Hydrochloride |
Fresenius Kabi USA |
Agila Specialties |
|
4/11/2014 |
Plavix |
Clopidogrel |
Sanofi Aventis |
Amneal Pharms |
|
4/14/2014 |
Imitrex |
Sumatriptan Succinate |
GlaxoSmithKline |
Agila Specialties |
|
4/14/2014 |
Intensol |
Diazepam |
Roxane |
Lannett Holdings |
|
4/15/2014 |
Altace |
Ramipril |
King Pharms |
Accord Healthcare |
|
4/15/2014 |
Lunesta |
Eszopiclone |
Sunovion Pharms |
Dr Reddy's Labs |
|
4/15/2014 |
Lunesta |
Eszopiclone |
Sunovion Pharms |
Glenmark Generics |
|
4/15/2014 |
Lunesta |
Eszopiclone |
Sunovion Pharms Inc |
Roxane |
|
4/16/2014 |
Ortho Evra |
Xulane |
Janssen Pharms |
Mylan Technologies |
|
4/17/2014 |
Dilantin |
Phenytoin |
Pfizer |
Taro |
|
4/22/2014 |
Reyataz |
Atazanavir Sulfate |
Bristol Myers Squibb |
Teva |
|
4/23/2014 |
Loestrin 24 Fe |
Norethindrone / Ethinyl Estradiol / Ferrous Fumarate |
Warner Chilcott |
Famy Care |
|
4/23/2014 |
Aldactone |
Spironolactone |
GD Searle |
Jubilant Life |
|
4/23/2014 |
Niaspan |
Niacin |
Abbvie |
Sun Pharma Global |
|
4/23/2014 |
Niaspan |
Niacin |
Abbvie |
Sun Pharma Global |
|
4/24/2014 |
Topicort |
Desoximetasone |
Taro |
Versapharm |
|
4/28/2014 |
Xylocaine |
Glydo |
Oak Pharms |
Sagent Pharms |
|
4/29/2014 |
Zutripro |
Hydrocodone Bitartrate / Chlorpheniramine Maleate / Pseudoephedrine Hydrochloride |
Cypress Pharm |
Paddock |
|
4/29/2014 |
Rezira |
Hydrocodone Bitarate / Pseudoephedrine Hydrochloride |
Cypress Pharm |
Paddock |
|
5/5/2014 |
Phentermine Hydrochloride |
Phentermine Hydrochloride |
Sandoz |
Invagen Pharms |
|
5/5/2014 |
Hectorol |
Doxercalciferol |
Genzyme |
Sandoz |
|
5/6/2014 |
Catapres-TTS-3 |
Clonidine |
Boehringer Ingelheim |
Watson Labs |
|
5/7/2014 |
Protonix |
Pantoprazole Sodium |
Wyeth |
Perrigo |
|
5/7/2014 |
Avandamet |
Rosiglitazone Maleate / Metformin Hydrochloride |
SB Pharmco |
Teva |
|
5/8/2014 |
Dymista |
Azelastine Hydrochloride |
Media Pharms |
Perrigo Israel |
|
5/9/2014 |
Avalide |
Irbesartan / Hydrochlorothiazide |
Sanofi Aventis US |
Prinston |
|
5/9/2014 |
Fludeoxyglucose F18 |
Fludeoxyglucose F-18 |
Feinstein |
UCSF Rodiopharm |
|
5/12/2014 |
Exalgo |
Hydromorphone Hydrochloride |
Mallinckrodt |
Actavis Labs FL |
|
5/12/2014 |
Rhinocort |
Budesonide |
AstraZeneca |
Apotex |
|
5/12/2014 |
Zyprexa Zydis |
Olanzapine |
Lilly |
Mylan Pharms |
|
5/15/2014 |
Zyprexa Zydis |
Olanzapine |
Lilly |
Aurobindo Pharma |
|
5/19/2014 |
Focalin XR |
Dexmethylphenidate Hydrochloride |
Novartis |
Teva |
|
5/19/2014 |
Focalin XR |
Dexmethylphenidate Hydrochloride |
Novartis |
Watson Labs |
|
5/22/2014 |
Zometa |
Zoledronic Acid |
Novartis |
Akorn |
|
5/27/2014 |
Pennsaid |
Diclofenac Sodium |
Mallinckrodt |
Apotex |
|
5/27/2014 |
Yaz |
drospirenone / ethinyl estradiol |
Bayer Healthcare |
Lupin |
|
5/27/2014 |
Malarone |
Atovaquone / Proguanil Hydrochloride |
GlaxoSmithKline |
Mylan Pharms |
|
5/28/2014 |
Tobi |
Tobramycin |
Novartis Pharms |
Akorn |
|
5/30/2014 |
Pepcid |
Famotidine |
Salix Pharms |
Hi-Tech Pharma |
|
5/30/2014 |
Celebrex |
Celecoxib |
GD Searle |
Mylan Pharms |
|
5/30/2014 |
Celebrex |
Celecoxib |
GD Searle |
Teva |
|
6/2/2014 |
Depakote ER |
Divalproex Sodium |
Abbvie |
Aurobindo Pharma |
|
6/2/2014 |
Ponstel |
Mefenamic Acid |
Shionogi |
Vintage Pharms |
|
6/3/2014 |
Roxicodone |
Oxycodone Hydrochloride |
Mallinckrodt |
Amneal Pharms |
|
6/3/2014 |
Mirapex |
Pramipexole Dihydrochloride |
Boehringer Ingelheim |
Strides Arcolab |
|
6/4/2014 |
Amitriptyline Hydrochloride |
Amitriptyline Hydrochloride |
Sandoz |
Accord Healthcare |
|
6/4/2014 |
Evoxac |
Cevimeline Hydrochloride |
Daiichi Sankyo |
Pack Pharms |
|
6/5/2014 |
Oxycodone Hydrochloride |
Oxycodone Hydrochloride |
Lehigh Valley |
Coastal Pharms |
|
6/5/2014 |
Oxsoralen-Ultra |
Methoxsalen |
Dow Pharm |
Strides Arcolab |
|
6/9/2014 |
Cymbalta |
Duloxetine Hydrochloride |
Lilly |
Alembic Pharms |
|
6/10/2014 |
Actonel |
Risedronate Sodium |
Warner Chilcott |
Apotex |
|
6/10/2014 |
Actonel |
Risedronate Sodium |
Warner Chilcott |
Mylan Pharms |
|
6/10/2014 |
Lunesta |
Eszopiclone |
Sunovion Pharms |
Orchid Healthcare |
|
6/10/2014 |
Actonel |
Risedronate Sodium |
Warner Chilcott |
Sun Pharma Global |
|
6/11/2014 |
Cardura |
Doxazosin Mesylate |
Pfizer |
Accord Healthcare |
|
6/11/2014 |
Cymbalta |
Duloxetine Hydrochloride |
Lilly |
Apotex |
|
6/11/2014 |
Cymbalta |
Duloxetine Hydrochloride |
Lilly |
Breckenridge Pharm |
|
6/11/2014 |
Tarceva |
Erlotinib Hydrochloride |
OSI Pharms |
Mylan Pharms |
|
6/12/2014 |
Lamictal CD |
Lamotrigine |
GlaxoSmithKline |
Alembic Pharms |
|
6/12/2014 |
Heparin |
Sodium Injection (Preservative Free) |
Fresenius Kabi USA/Hikma Maple |
Shenzhen Techdow |
|
6/12/2014 |
Heparin |
Sodium Injection (Plastic Container) |
Fresenius Kabi USA/Hikma Maple |
Shenzhen Techdow |
|
6/12/2014 |
Heparin |
Sodium Injection |
Fresenius Kabi USA/Hikma Maple |
Shenzhen Techdow |
|
6/13/2014 |
Codeine Sulfate |
Codeine Sulfate |
Roxane |
Lannett Holdings |
|
6/13/2014 |
Actonel |
Risedronate Sodium |
Warner Chilcott |
Teva |
|
6/18/2014 |
Zovirax |
Acyclovir |
Valeant Bermuda |
Amneal Pharms |
|
6/18/2014 |
Eloxatin/Oxaliplatin |
Oxaliplatin |
Sanofi Aventis US/Teva |
Jiangsu Hengrui Med |
|
6/18/2014 |
Diuril |
Chlorothiazide Sodium |
Oak Pharms Akorn |
Mylan Institutional |
|
6/19/2014 |
Bromday |
Bromfenac Sodium |
Bausch and Lomb |
Apotex |
|
6/20/2014 |
Marinol |
Dronabinol |
Abbvie |
Akorn |
|
6/23/2014 |
Bromday |
Bromfenac Sodium |
Bausch and Lomb |
Apotex |
|
6/23/2014 |
Lovenox |
Enoxaparin Sodium |
Sanofi Aventis US |
Teva |
|
6/24/2014 |
Zemplar |
Paricalcitol |
Abbvie |
Anchen Pharms |
|
6/24/2014 |
Zemplar |
Paricalcitol |
Abbvie |
Dr Reddy's Labs |
|
6/24/2014 |
Lovazas |
Omega-3-Acid Ethyl Esters |
SmithKline Beecham |
Par Pharm |
|
6/24/2014 |
Aldara |
Imiquimod |
Medicis |
Strides Arcolab |
|
6/26/2014 |
Diovan |
Valsartan |
Novartis |
OHM Labs |
|
6/27/2014 |
Doxil |
Doxorubicin HCl |
Janssen Pharms |
Actavis |
|
6/27/2014 |
Opana ER |
Oxymorphone HCl |
Endo Pharms |
Mallinckrodt |
|
6/27/2014 |
DDAVP |
Desmopressin Acetate |
Sanofi Aventis |
Mylan Pharms |
|
6/27/2014 |
Suboxone |
Buprenorphine HCl / Naloxone HCl |
Rickitt Benckiser |
Roxane |
|
6/27/2014 |
Ammonia N-12 |
Ammonia N-13 |
Feinstein |
University of Texas MD Anderson |
|
6/30/2014 |
Acova |
Argatroban |
Pfizer |
Mylan Pharms |
|
6/30/2014 |
Acova |
Argatroban |
Pfizer |
Par Pharm |
