Approval Date |
Reference Listed Drug |
Generic Drug Name |
NDA Holder |
ANDA Applicant |
10/2/2014 |
Adenoscan |
Adenosine |
Astellas |
Akorn |
10/6/2014 |
PhosLo Gelcaps |
Calcium Acetate |
Fresenius Medical |
Amneal Pharms |
10/8/2014 |
Patanase |
Olopatadine Hydrochloride |
Alcon Pharms |
Apotex |
10/15/2014 |
Ritalin LA |
Methylphenidate Hydrochloride |
Novartis |
Barr Labs |
10/21/2014 |
Fludeoxyglucose F18 |
Fludeoxyglucose F18 |
Feinstein |
Global Isotopes |
10/21/2014 |
Sodium Fluoride F-18 |
Sodium Fluoride F-18 |
Houston Cyclotron |
Global Isotopes |
10/23/2014 |
Ammonia N 13 |
Ammonia N 13 |
Feinstein |
Global Isotopes |
10/24/2014 |
Astelin |
Azelastine Hydrochloride |
Meda Pharms |
Roxane |
10/24/2014 |
Opana ER |
Oxymorphone Hydrochloride Extended-Release |
Endo Pharms |
Par Pharm |
10/24/2014 |
Stromectol |
Ivermectin |
Merck Sharp Dohme |
Edenbridge Pharms |
10/27/2014 |
Differin |
Adapalene |
Galderma Labs |
Actavis Mid Atlantic |
10/27/2014 |
Rapamune |
Sirolimus |
PF Prism CV |
Dr Reddy's Labs |
10/27/2014 |
Soma |
Carisoprodol |
Meda Pharms |
Orient Pharma |
10/27/2014 |
Viramune XR |
Nevirapine |
Boehringer Ingelheim |
Mylan |
10/28/2014 |
Soma |
Carisoprodol |
Meda Pharms |
Natco Pharma |
10/28/2014 |
Metoprolol Tartrate |
Metoprolol Tartrate |
Mylan |
Rubicon Res PVT |
10/28/2014 |
Seroquel |
Quetiapine Fumarate |
AstraZeneca |
Alembic Pharms |
10/28/2014 |
Rezira |
Hydrocodone Bitartrate / Pseudoephedrine Hydrochloride |
Cypress Pharm |
Tris Pharma |
10/28/2014 |
Mirapex |
Pramipexole Dihydrochloride |
Boehringer Ingelheim |
Sciegen Pharms |
10/29/2014 |
Oxytocin / Oxytocin /Pitocin |
Oxytocin |
Fresenius Kabi USA / Hikma Maple / Par Sterile Products |
Sagent Pharms |
10/29/2014 |
Femara |
Letrozole |
Novartis Pharms |
Lannett Holdings |
10/29/2014 |
Celebrex |
Celecoxib |
GD Searle |
Lupin |
10/29/2014 |
Isoniazid |
Isoniazid |
Sandoz |
ThePharmaNetwork |
10/29/2014 |
Aricept |
Donepezil Hydrochloride |
Eisai |
TWI Pharms |
10/29/2014 |
Aricept |
Donepezil Hydrochloride |
Eisai |
Sciegen Pharms |
10/29/2014 |
Zosyn |
Piperacillin / Tazobactam |
Wyeth |
Sandoz |
10/29/2014 |
Fludeoxyglucose F18 |
Fludeoxyglucose F18 |
Feinstein |
Trustees Univ PA |
10/29/2014 |
Fludeoxyglucose F18 |
Fludeoxyglucose F18 |
Feinstein |
Children's Hospital MI |
10/29/2014 |
Fludeoxyglucose F18 |
Fludeoxyglucose F18 |
Feinstein |
SPDC |
10/29/2014 |
Sodium Fluoride F-18 |
Sodium Fluoride F18 |
Houston Cyclotron |
Essential Isotopes |
10/30/2014 |
Myfortic |
Mycophenolic Acid |
Novartis |
Teva Pharms USA |
10/30/2014 |
Loestrin 24 FE |
Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate |
Warner Chilcott |
Famy Care |
10/30/2014 |
Singulair |
Montelukast Sodium |
Merck |
Unimark Remedies |
10/30/2014 |
Singulair |
Montelukast Sodium |
Merck |
Unimark Remedies |
10/30/2014 |
Ammonia N 13 |
Ammonia N 13 |
Feinstein |
Brigham Women's Hosp |
10/30/2014 |
Fludeoxyglucose F18 |
Fludeoxyglucose F18 |
Feinstein |
Brigham Women's Hosp |
10/30/2014 |
Fludeoxyglucose F18 |
Fludeoxyglucose F18 |
Feinstein |
Hot Shots NM |
10/31/2014 |
Prilosec |
Omeprazole |
AstraZeneca |
Glenmark Generics |
10/31/2014 |
Antara (Micronized) |
Fenofibrate |
Lupin Atlantis |
Ranbaxy Labs |
10/31/2014 |
Desowen |
Desonide |
Galderma Labs |
Taro |
10/31/2014 |
Luvox CR |
Fluvoxamine Maleate |
Jazz Pharms |
Torrent Pharms |
10/31/2014 |
Epivir |
Lamivudine |
ViiV Healthcare |
Silarx Pharms |
10/31/2014 |
Paxil |
Paroxetine |
Apotex Technologies |
Prinston |
10/31/2014 |
Wellbutrin SR |
Bupropion Hydrochloride |
GlaxoSmithKline |
Torrent Pharms |
10/31/2014 |
Cyclophosphamide / Cytoxan |
Cyclophosphamide |
Baxter Healthcare |
Jiangsu Hengrui Med |
11/3/2014 |
Micardis |
Telmisartan |
Boehringer Ingelheim |
Sandoz |
11/4/2014 |
Valcyte |
Valganciclovir Hydrochloride |
Hoffmann LA Roche |
Endo Pharms |
11/4/2014 |
Valcyte |
Valganciclovir Hydrochloride |
Hoffmann LA Roche |
Dr Reddy's Labs |
11/5/2014 |
Taxotere |
Docetaxel |
Sanofi Aventis US |
Dr Reddy's Labs |
11/7/2014 |
Zoloft |
Sertraline Hydrochloride |
Pfizer |
Accord Healthcare |
11/13/2014 |
Zomig |
Zolmitriptan |
IPR |
Sun Pharma Global |
11/14/2014 |
Cellcept |
Mycophenolate Mofetil |
Roche Palo |
Alkem Labs |
11/18/2014 |
Allegra-D 12 |
Fexofenadine Hydrochloride / Pseudoephedrine Hydrochloride |
Sanofi Aventis US |
Dr Reddy's Labs |
11/18/2014 |
Brimonidine Tartrate |
Brimonidine Tartrate |
Bausch and Lomb |
Indoco Remedies |
11/19/2014 |
Yasmin |
Drospirenone / Ethinyl Estradiol |
Bayer Healthcare |
Novast Labs |
11/19/2014 |
Sodium Fluoride F-18 |
Sodium Fluoride F-18 |
Houston Cyclotron |
The Feinstein Inst |
11/20/2014 |
Propecia |
Finasteride |
Merck |
Cipla |
11/20/2014 |
Zomig |
Zolmitriptan |
IPR |
Jubilant Generics |
11/20/2014 |
Ammonia N 13 |
Ammonia N 13 |
Feinstein |
MIPS CRF |
11/24/2014 |
Zometa |
Zoledronic Acid |
Novartis |
Sagent Pharms |
11/24/2014 |
Pennsaid |
Diclofenac Sodium |
Mallinckrodt |
Paddock |
11/25/2014 |
Zocor |
Simvastatin |
Merck |
Hetero Labs |
11/25/2014 |
Precedex |
Dexmedetomidine Hydrochloride |
Hospira |
Akorn |
11/25/2014 |
Pennsaid |
Diclofenac Sodium |
Mallinckrodt |
Watson Labs |
11/26/2014 |
Revatio |
Sildenafil Citrate |
Pfizer |
Hetero Labs |
11/26/2014 |
Pennsaid |
Diclofenac Sodium |
Mallinckrodt |
Taro |
11/26/2014 |
Zutripro |
Hydrocodone Bitartrate / Chlorpheniramine Maleate / Pseudoephedrine Hydrochloride |
Cypress Pharm |
Tris Pharma |
11/26/2014 |
Synalgos-DC-A |
Acetaminophen / Caffeine / Dihydrocodeine Bitartrate |
Leitner Pharms |
Wraser Pharms |
11/28/2014 |
Dilantin |
Phenytoin |
Pfizer |
Corepharma |
11/28/2014 |
Kayexalate |
Sodium Polystyrene Sulfonate |
Covis Pharma |
Nuvo Pharm |
11/28/2014 |
Sodium Fluoride F-18 |
Sodium Fluoride F-18 |
Houston Cyclotron |
NCM USA Bronx |
12/1/2014 |
Latisse |
Bimatoprost |
Allergan |
Apotex |
12/2/2014 |
Protonix |
Pantoprazole Sodium |
Wyeth Pharms |
Orchid Healthcare |
12/4/2014 |
Mirapex |
Pramipexole Dihydrochloride |
Boehringer Ingelheim |
Sandoz |
12/5/2014 |
Phentermine Hydrochloride |
Phentermine Hydrochloride |
Sandoz |
Ken Lifescience |
12/8/2014 |
Nordette-28 |
Levonorgestrel / Ethinyl Estradiol |
Teva Branded Pharm |
Haupt Pharma |
12/8/2014 |
Levonorgestrel / Ethinyl Estradiol |
Levonorgestrel / Ethinyl Estradiol |
Watson Labs |
Famy Care |
12/12/2014 |
Rocaltrol |
Calcitriol |
Validus Pharms |
Strides Arcolab |
12/12/2014 |
Taclonex |
Calcipotriene / Betamethasone Dipropionate |
Leo Pharma |
Perrigo Israel |
12/15/2014 |
Cellcept |
Mycophenolate Mofetil |
Roche Palo |
Cadista Pharms |
12/15/2014 |
Cellcept |
Mycophenolate Mofetil |
Roche Palo |
Cadista Pharms |
12/15/2014 |
Opana |
Oxymorphone Hydrochloride |
Endo Pharms |
Corepharma |
12/18/2014 |
Wellbutrin XL |
Bupropion Hydrochloride |
Valeant |
Sun Pharma Global |
12/18/2014 |
Cosopt |
Dorzolamide Hydrochloride / Timolol Maleate |
Oak Pharms |
Lannett Holdings |
12/18/2014 |
Roxicet |
Oxycodone Hydrochloride / Acetaminophen |
Roxane |
Vintage Pharms |
12/18/2014 |
Fludeoxyglucose F18 |
Fludeoxyglucose F18 |
Feinstein |
Shertech Labs |
12/18/2014 |
Ammonia N 13 |
Ammonia N 13 |
Feinstein |
WI Medical Cyclotron |
12/18/2014 |
Epivir |
Lamivudine |
ViiV Healthcare |
Lupin |
12/19/2014 |
Vivelle-Dot |
Estradiol |
Novartis |
Mylan Technologies |
12/19/2014 |
Acetazolamide Sodium |
Acetazolamide Sodium |
X Gen Pharms |
Emcure Pharms |
12/23/2014 |
Prometh VC w/Codeine |
Promethazine Hydrochloride / Phenylephrine Hydrochloride w/Codeine Phosphate |
Actavis Mid Atlantic |
Hi-Tech Pharma |
12/23/2014 |
Pometh VC Plain |
Phenylephrine Hydrochloride / Promethazine Hydrochloride |
Actavis Mid Atlantic |
Hi-Tech Pharmacal |
12/29/2014 |
Kadian |
Morphine Sulfate |
Watson Labs |
Teva Pharms USA |