Approval Date |
Reference Listed Drug |
Generic Drug Name |
NDA Holder |
ANDA Applicant |
4/2/2013 |
Zithromax |
Azithromycin |
Pfizer |
Sun Pharm Indus |
4/3/2013 |
Ampicillin Sodium |
Ampicillin Sodium |
Sandoz |
ACS Dobfar Spa |
4/3/2013 |
Ampicillin Sodium |
Ampicillin Sodium |
Sandoz |
ACS Dobfar Spa |
4/3/2013 |
Lunesta |
Eszopiclone |
Sunovion Pharms Inc |
Sun Pharma Global |
4/3/2013 |
Zovirax |
Acyclovir |
Valeant Int'l |
Mylan Pharms |
4/4/2013 |
Soriatane |
Acitretin |
Stiefel Labs |
Barr Labs |
4/4/2013 |
Gastrocrom |
Cromolyn Sodium |
Meda Pharms |
Micro Labs |
4/4/2013 |
Soriatane |
Acitretin |
Stiefel Labs |
Barr Labs |
4/4/2013 |
Cleocin Phosphate in 5% Dextrose in Plastic Container |
Clindamycin Phosphate in 5% Dextrose in Plastic Container |
Pharmacia and Upjohn |
Akorn |
4/5/2013 |
Lipitor |
Atorvastatin Calcium |
Pfizer |
Kudco Ireland |
4/5/2013 |
Reclast |
Zoledronic Acid |
Novartis |
Hospira |
4/8/2013 |
Risperdal |
Risperidone |
Janssen Pharms |
Sun Pharm Indus |
4/10/2013 |
Seasonique |
Daysee |
Teva Branded Pharm |
Lupin |
4/10/2013 |
Orapred ODT |
Prednisolone Sodium Phosphate |
Shionogi |
Mylan Pharms |
4/12/2013 |
Percocet |
Oxycodone / Acetaminophen |
Vintage Pharms |
Actavis Elizabeth |
4/15/2013 |
Acetaminophen and Codeine Phosphate; Tylenol w/Codeine No. 3; Acetaminophen and Codeine Phosphate |
Acetaminophen / Codeine Phosphate |
Mallinckrodt; Janssen Pharms; Teva |
Aurolife Pharma |
4/16/2013 |
Actoplus Met |
Pioglitazone Hydrochloride / Metformin Hydrochloride |
Takeda Pharms USA |
Sandoz |
4/19/2013 |
Zegerid |
Omeprazole / Sodium Bicarbonate |
Santarus |
Par Pharm |
4/19/2013 |
Reglan |
Metoclopramide Hydrochloride |
Baxter Healthcare |
BD RX |
4/19/2013 |
Diovan HCT |
Valsartan / Hydrochlorothiazide |
Novartis |
MacLeods Pharms |
4/23/2013 |
Luvox CR |
Fluvoxamine Maleate |
Jazz Pharms |
Actavis Elizabeth |
4/23/2013 |
Imitrex |
Sumatriptan Succinate |
GlaxoSmithKline |
Aurobindo Pharma |
4/24/2013 |
Promethazine Hydrochloride and Codeine Phosphate |
Promethazine Hydrochloride / Codeine Phosphate |
Actavis Mid Atlantic |
Amneal Pharms |
4/24/2013 |
Ortho-Novum 7/7/7-28 |
Primella 7/7/7 |
Janssen Pharms |
Lupin |
4/24/2013 |
Ortho-Novum 1/35-28 |
Primella 1/35 |
Janssen Pharms |
Lupin |
4/25/2013 |
Duricef |
Cefadroxil |
Warner Chilcott |
Aurobindo Pharma |
4/25/2013 |
Opana |
Oxymorphone Hydrochloride |
Endo Pharms |
Mallinckrodt Inc |
4/25/2013 |
Procardia |
Nifedipine |
Pfizer |
Emcure Pharms USA |
4/26/2013 |
Xopenex |
Levalbuterol Hydrochloride |
Sunovion |
Teva Pharms USA |
4/29/2013 |
Adderall XR 30 |
Amphetamine / Dextroamphetamine |
Shire |
Teva Pharms USA |
4/29/2013 |
Lopressor |
Metoprolol Tartrate |
Novartis |
Claris LifeSciences |
4/29/2013 |
Norvasc |
Amlodipine Besylate |
Pfizer |
Accord Healthcare |
4/29/2013 |
Ocuflox |
Ofloxacin |
Allergan |
Altaire Pharms |
4/29/2013 |
Accupril |
Quinapril Hydrochloride |
Pfizer Pharms |
Aurobindo Pharma |
4/30/2013 |
Doryx |
Doxycycline Hyclate |
Mayne Pharma |
Heritage Pharms |
4/30/2013 |
Cleocin |
Clindamycin Palmitate Hydrochloride |
Pharmacia and Upjohn |
Aurobindo Pharma |
4/30/2013 |
Flomax |
Tamsulosin Hydrochloride |
Boehringer Ingelheim |
Aurobindo Pharma |
5/3/2013 |
Atacand |
Candesartan Cilexetil |
AstraZeneca |
Sandoz |
5/3/2013 |
Hydralazine Hydrochloride |
Hydralazine Hydrochloride |
Pliva |
Strides Arcolab |
5/6/2013 |
Zyloprim |
Allopurinol |
Prometheus Labs |
Accord Healthcare |
5/7/2013 |
Gemzar |
Gemcitabine Hydrochloride |
Eli Lilly |
Sagent Pharms |
5/7/2013 |
Gemzar |
Gemcitabine Hydrochloride |
Eli Lilly |
Pharmaforce |
5/7/2013 |
Gemzar |
Gemcitabine Hydrochloride |
Eli Lilly |
Jiangsu Hansoh Pharm |
5/7/2013 |
Zometa |
Zoledronic Acid |
Novartis |
Pharms |
5/7/2013 |
Gemcitabine Hydrochloride |
Gemcitabine Hydrochloride |
Hospira |
Dr Reddy's Labs |
5/8/2013 |
Triaminolone Acetonide |
Triamcinolone Acetonide |
Morton Grove / Wockhardt |
Versapharm |
5/9/2013 |
Arthrotec |
Diclofenac Sodium / Misoprostol |
GD Searle |
Sandoz |
5/10/2013 |
Hydrocodone Bitartrate and Acetaminophen |
Hydrocodone Bitartrate / Acetaminophen |
Mikart |
PAI |
5/13/2013 |
Minocycline Hydrochloride |
Minocycline Hydrochloride |
Teva |
Caraco |
5/13/2013 |
Comtan |
Entacapone |
Orion Pharma |
Mylan Pharms |
5/14/2013 |
Zomig |
Zolmitriptan |
IPR |
Glenmark Generics |
5/14/2013 |
Zomig |
Zolmitriptan |
IPR |
Apotex |
5/14/2013 |
Zomig-ZMT |
Zolmitriptan |
AstraZeneca |
Apotex |
5/14/2013 |
Zomig |
Zolmitriptan |
AstraZeneca |
Glenmark Generics |
5/14/2013 |
Zomig |
Zolmitriptan |
IPR |
Mylan Pharms |
5/15/2013 |
Zomig-ZMT |
Zolmitriptan |
AstraZeneca |
Zydus Pharms USA |
5/16/2013 |
Exelon |
Rivastigmine Tartrate |
Novartis |
Apotex |
5/16/2013 |
Ultram |
Tramadol Hydrochloride |
Janssen Pharms |
Accord Healthcare |
5/16/2013 |
Femara |
Letrozole |
Novartis |
Jiangsu Hengrui Med |
5/21/2013 |
Imitrex |
Sumatriptan Succinate |
GlaxoSmithKline |
Hikma Pharms |
5/24/2013 |
Rocaltrol |
Calcitriol |
Validus Pharms |
Banner Pharmacaps |
5/24/2013 |
Sanctura XR |
Trospium Chloride |
Allergan |
Paddock |
5/28/2013 |
Plavix |
Clopidogrel Bisulfate |
Sanofi Aventis US |
Actavis Totowa |
5/28/2013 |
Vicoprofen |
Hydrocodone Bitartrate / Ibuprofen |
Abbvie |
Sun Pharm Indus |
5/28/2013 |
Vfend |
Voriconazole |
Pfizer |
Mylan Pharms |
5/28/2013 |
Metoprolol Tartrate |
Metoprolol Tartrate |
Mylan |
Alembic Pharms |
5/29/2013 |
Dextroamphetamine Sulfate |
Dextroamphetamine Sulfate |
Outlook Pharms |
Tris Pharma |
5/30/2013 |
Avodart |
Dutasteride |
GlaxoSmithKline |
Banner Pharmacaps |
6/3/2013 |
Vistaril |
Hydroxyzine Pamoate |
Pfizer |
Emcure Pharms USA |
6/3/2013 |
Depo-Testosterone |
Testosterone Cypionate |
Pharmacia and Upjohn |
Sun Pharm Indus |
6/3/2013 |
Kadian |
Morphine Sulfate |
Watson Labs |
Upsher Smith |
6/3/2013 |
Zometa |
Zoledronic Acid |
Novartis |
Hikma Farmaceutica |
6/3/2013 |
Atacand HCT |
Candesartan Cilexetil / Hydrochlorothiazide |
AstraZeneca |
Apotex |
6/3/2013 |
Atacand HCT |
Candesartan Cilexetil / Hydrochlorothiazide |
AstraZeneca |
Dr Reddy's Labs |
6/5/2013 |
Levaquin |
Levofloxacin |
Janssen Pharms |
Claris LifeSciences |
6/10/2013 |
Biaxin |
Clarithromycin |
Abbvie |
Allied Pharma |
6/12/2013 |
Lexapro |
Escitalopram Oxalate |
Forest Labs |
Silarx Pharms |
6/12/2013 |
Micronor |
Norethindrone |
Janssen Pharms |
Famy Care |
6/13/2013 |
Cellcept |
Mycophenolate Mofetil |
Roche Palo |
Alkem Labs |
6/13/2013 |
Catapres |
Clonidine Hydrochloride |
Boehringer Ingelheim |
Carlsbad |
6/14/2013 |
Lamictal |
Lamotrigine |
GlaxoSmithKline |
Alkem Labs |
6/14/2013 |
Cyklokapron |
Tranexamic Acid |
Pharmacia and Upjohn |
Custopharm |
6/17/2013 |
Lamictal XR |
Lamotrigine |
GlaxoSmithKline |
Handa Pharms |
6/18/2013 |
Rilutek |
Riluzole |
Covis Pharma |
Apotex |
6/18/2013 |
Rilutek |
Riluzole |
Covis Pharma |
Glenmark Generics |
6/18/2013 |
Rilutek |
Riluzole |
Covis Pharma |
Sun Pharm Indus |
6/19/2013 |
Levaquin in Dextrose 5% in Plastic Container |
Levofloxacin in Dextrose 5% in Plastic Container |
Janssen Pharms |
Fresenius Kabi USA |
6/19/2013 |
Lamictal XR |
Lamotrigine |
GlaxoSmithKline |
Dr Reddy's Labs |
6/21/2013 |
Carbatrol |
Carbamazepine |
Shire |
Taro |
6/21/2013 |
Skelaxin |
Metaxalone |
King Pharms |
Amneal Pharms |
6/26/2013 |
Keppra |
Levetiracetam |
UCB |
Sagent Pharms |
6/26/2013 |
Hycamtin |
Topotecan Hydrochloride |
GlaxoSmithKline |
Accord Healthcare |
6/27/2013 |
Coumadin |
Warfarin Sodium |
Bristol-Myers Squibb |
IPCA Labs |
6/27/2013 |
Fludeoxyglucose F18 |
Fludeoxyglucose F18 |
Weill Medical College |
UCLA Biomedical |
6/27/2013 |
Ammonia N 13 |
Ammonia N 13 |
Feinstein |
UCLA Biomedical |
6/28/2013 |
Tofranil-PM |
Imipramine Pamoate |
Mallinckrodt |
Mylan Pharms |
6/28/2013 |
FLUORINE F-18 |
Sodium Fluoride F-18 |
GE Healthcare |
MCPRF |