Approval Date |
Reference Listed Drug |
Generic Drug Name |
NDA Holder |
ANDA Applicant |
1/3/2013 |
Zofran and Zofran Preservative Free |
Ondansetron Hydrochloride Preservative Free |
GlaxoSmithKline |
Emcure Pharms |
1/4/2013 |
Duetact |
Pioglitazone Hydrochloride and Glimepiride |
Takeda Pharms USA |
Sandoz |
1/4/2013 |
Flomax |
Tamsulosin Hydrochloride |
Boehringer Ingelheim |
Anchen Pharms |
1/4/2013 |
Lamictal XR |
Lamotrigine |
SmithKline Beecham |
Wockhardt |
1/7/2013 |
Revatio |
Sildenafil Citrate |
Pfizer |
Teva Pharms |
1/7/2013 |
Ceftriaxone |
Ceftriaxone |
Sandoz |
Strides Arcolab |
1/9/2013 |
Bromday |
Bromfenac Sodium |
ISTA Pharms |
Pharmaforce |
1/10/2013 |
Antara (Micronized) |
Fenofibrate (Micronized) |
Lupin Atlantis |
Mylan Pharms |
1/14/2013 |
Taclonex |
Calcipotriene and Betamethasone Dipropionate |
Leo Pharma |
Tolmar |
1/16/2013 |
Avinza |
Morphine Sulfate |
King Pfizer |
Actavis Elizabeth |
1/17/2013 |
Felodipine |
Felodipine |
Mylan |
Aurobindo Pharma |
1/18/2013 |
Levonorgestrel and Ethinyl Estradiol |
Levonorgestrel and Ethinyl Estradiol |
Watson Labs |
Lupin |
1/18/2013 |
Oxacillin Sodium |
Oxacillin Sodium |
Sandoz |
Aurobindo Pharma |
1/18/2013 |
Oxacillin Sodium |
Oxacillin Sodium |
Sandoz |
Aurobindo Pharma |
1/18/2013 |
Lamictal XR |
Lamotrigine |
SmithKline Beecham |
Par Pharm |
1/23/2013 |
Levonorgestrel/Plan B |
Levonorgestrel |
Watson Labs/Teva Branded Pharm |
Lupin |
1/24/2013 |
Bactroban |
Mupirocin |
GlaxoSmithKline |
Glenmark Generics |
1/24/2013 |
Levaquin |
Levofloxacin |
Janssen Pharms |
Aurobindo Pharma |
1/24/2013 |
Levaquin |
Levofloxacin |
Janssen Pharms |
Emcure Pharms |
1/25/2013 |
Avandia |
Rosiglitazone Maleate |
SB Pharmco |
Teva |
1/25/2013 |
DDAVP |
Desmopressin Acetate |
Sanofi Aventis US |
Sun Pharm Indus |
1/30/2013 |
Ortho Tri-Cyclen |
Tri-Estarylla |
Janssen Pharms |
Sandoz |
1/30/2013 |
Ortho Cyclen-28 |
Estarylla |
Janssen Pharms |
Sandoz |
1/30/2013 |
Opana |
Oxymorphone Hydrochloride |
Endo Pharms |
Avanthi |
2/5/2013 |
Ponstel |
Mefenamic Acid |
Shionogi |
Cypress Pharm |
2/5/2013 |
Cogentin |
Benztropine Mesylate |
Oak Pharms Akorn |
Navinta |
2/5/2013 |
Eliphos |
Calcium Acetate |
Cypress Pharm |
Invagen Pharms |
2/6/2013 |
Actos |
Pioglitazone Hydrochloride |
Takeda Pharms USA |
MacLeods Pharms |
2/7/2013 |
Phoslo Gelcaps |
Calcium Acetate |
Fresenius Medical |
Invagen Pharms |
2/8/2013 |
Doxil |
Doxorubicin Hydrochloride |
Janssen Research and Development |
Sun Pharma Global |
2/8/2013 |
Sinemet CR |
Carbidopa and Levodopa |
Merck Sharp Dohme |
Accord Healthcare |
2/12/2013 |
Adderall XR 30 |
Dextroamp Saccharate, AMP Aspartate, Dextroamp Sulfate and Amp Sulfate |
Shire |
Barr Labs |
2/12/2013 |
Seroquel |
Quetiapine Fumarate |
AstraZeneca |
Alkem Labs |
2/12/2013 |
Sulfamylon |
Mafenide Acetate |
Mylan |
Par Form |
2/13/2013 |
Actos |
Pioglitazone Hydrochloride |
Takeda Pharms USA |
Synthon Pharms |
2/13/2013 |
Actos |
Pioglitazone Hydrochloride |
Takeda Pharms USA |
Sandoz |
2/13/2013 |
Actos |
Pioglitazone Hydrochloride |
Takeda Pharms USA |
Torrent Pharms |
2/13/2013 |
Actos |
Pioglitazone Hydrochloride |
Takeda Pharms USA |
Accord Healthcare |
2/13/2013 |
Oxytocin |
Oxytocin |
Baxter Healthcare Corp |
Hikma Farmaceutica |
2/13/2013 |
Actos |
Pioglitazone Hydrochloride |
Takeda Pharms USA |
Aurobindo Pharma |
2/13/2013 |
Actoplus Met |
Pioglitazone Hydrochloride and Metformin Hydrochloride |
Takeda Pharms USA |
Aurobindo Pharma |
2/13/2013 |
Actoplus Met |
Pioglitazone Hydrochloride and Metformin Hydrochloride |
Takeda Pharms USA |
Torrent Pharms |
2/13/2013 |
Actos |
Pioglitazone Hydrochloride |
Takeda Pharms USA |
Zydus Pharms USA |
2/14/2013 |
Urso Forte |
Ursodiol |
Aptalis Pharma US |
Par Pharm |
2/14/2013 |
Fludeoxyglucose F18 |
Fludeoxyglucose F18 |
Feinstein |
Houston Cyclotron |
2/19/2013 |
Lorazepam Intensol |
Lorazepam |
Roxane |
Lupin |
2/22/2013 |
Zofran Preservative free |
Ondansetron Hydrochloride Preservative Free |
GlaxoSmithKline |
Claris Lifesciences |
2/22/2013 |
Zofran |
Ondansetron Hydrochloride |
GlaxoSmithKline |
Claris Lifesciences |
2/22/2013 |
Depakene |
Valproic Acid |
AbbVie |
Sun Pharm Indus |
2/22/2013 |
Suboxone |
Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate |
Reckitt Benckiser |
Actavis Elizabeth |
2/22/2013 |
Zantac |
Ranitidine Hydrochloride |
Covis Pharma |
Zydus Pharms USA |
2/22/2013 |
Potassium Chloride |
Potassium Chloride |
Watson Labs Florida |
Amneal Pharms |
2/22/2013 |
Plan B One-Step |
Levonorgestrel |
Duramed |
Novel Labs |
2/22/2013 |
Suboxone |
Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate |
Reckitt Benckiser |
Amneal Pharms |
2/22/2013 |
Avalide |
Irbesartan and Hydrochlorothiazide |
Sanofi Aventis US |
Aurobindo Pharma |
2/25/2013 |
Fosamax |
Alendronate Sodium |
Merck |
Roxane |
2/25/2013 |
Ravatio |
Sildenafil Citrate |
Pfizer |
Actavis Pharma |
2/25/2013 |
Aricept |
Donepezil Hydrochloride |
Eisai |
Alembic Pharms |
2/25/2013 |
Ammonia N 13 |
Ammonia N 13 |
Feinstein |
MCPRF |
2/25/2013 |
Ammonia N 13 |
Ammonia N 13 |
Feinstein |
Cardinal Health 414 |
2/27/2013 |
Topamax |
Topiramate |
Janssen Pharms |
Actavis Totowa |
2/27/2013 |
Seroquel |
Quetiapine Fumarate |
AstraZeneca |
Actavis Pharma |
2/27/2013 |
Avalide |
Irbesartan and Hydrochlorothiazide |
Sanofi Aventis US |
Lupin |
2/28/2013 |
Revatio |
Sildenafil Citrate |
Pfizer |
Amneal Pharms |
2/28/2013 |
Keppra |
Levetiracetam |
UCB Inc |
Hetero Drugs |
3/1/2013 |
Travatan Z |
Travoprost |
Alcon Pharms |
Par Pharm |
3/1/2013 |
Hyzaar |
Losartan Potassium and Hydrochlorothiazide |
Merck |
IPCA Labs |
3/4/2013 |
Zometa |
Zoledronic Acid |
Novartis |
Sun Pharma Global |
3/4/2013 |
Zometa |
Zoledronic Acid |
Novartis |
Pharmaceutics |
3/4/2013 |
Zometa |
Zoledronic Acid |
Novartis |
Dr. Reddy's Labs |
3/4/2013 |
Hydralazine Hydrochloride |
Hydralazine Hydrochloride |
Pliva |
Actavis Pharma |
3/4/2013 |
Coumadin |
Warfarin Sodium |
Bristol Myers Squibb |
Amneal Pharms |
3/4/2013 |
Zometa |
Zoledronic Acid |
Novartis |
Actavis |
3/4/2013 |
Zometa |
Zoledronic Acid |
Novartis |
Agila Speclts |
3/4/2013 |
Zometa |
Zoledronic Acid |
Novartis |
Sun Pharma Global |
3/7/2013 |
Ortho-Cept |
Enskyce |
Janssen Pharms |
Lupin |
3/8/2013 |
Cabergoline |
Cabergoline |
Par Pharm |
Apotex |
3/12/2013 |
Actos |
Pioglitazone Hydrochloride |
Takeda Pharms USA |
Dr. Reddy's Labs |
3/12/2013 |
Accuretic |
Quinapril Hydrochloride and Hydrochlorothiazide |
Pfizer Pharms |
Apotex |
3/12/2013 |
Zometa |
Zoledronic Acid |
Novartis |
Emcure Pharms |
3/13/2013 |
Luvox CR |
Fluvoxamine Maleate |
Jazz Pharms |
Anchen Pharms |
3/14/2013 |
Xylocaine and Xylocaine Preservative |
Lidocaine Hydrochloride Preservative Free |
Fresenius Kabi USA |
Aurobindo Pharma |
3/14/2013 |
Xylocaine and Xylocaine Preservative |
Lidocaine Hydrochloride Preservative Free |
Fresenius Kabi USA |
Aurobindo Pharma |
3/15/2013 |
Xopenex |
Levalbuterol Hydrochloride |
Sunovion |
DEY |
3/18/2013 |
Doxorubicin Hydrochloride |
Doxorubicin Hydrochloride |
Bedford |
Sagent Pharms |
3/18/2013 |
Vibramycin |
Doxycycline |
Pfizer |
Lupin |
3/19/2013 |
Inversine |
Mecamylamine Hydrochloride |
Targacept |
Nexgen Pharma |
3/21/2013 |
Diovan HCT (25mg; 320 mg) |
Valsartan and Hydrochlorothiazide |
Novartis |
Lupin |
3/21/2013 |
Diovan HCT (25mg; 320 mg) |
Valsartan and Hydrochlorothiazide |
Novartis |
Watson Labs |
3/21/2013 |
Diovan HCT (25mg; 320 mg) |
Valsartan and Hydrochlorothiazide |
Novartis |
Alembic |
3/21/2013 |
Diovan HCT (25mg; 320 mg) |
Valsartan and Hydrochlorothiazide |
Novartis |
Aurobindo Pharma |
3/21/2013 |
Diovan HCT (25mg; 320 mg) |
Valsartan and Hydrochlorothiazide |
Novartis |
Apotex |
3/22/2013 |
Buphenyl |
Sodium Phenylbutyrate |
Medicis |
Sigmapharm Labs |
3/25/2013 |
Ambien CR |
Zolpidem Tartrate |
Sanofi Aventis US |
Watson Labs |
3/25/2013 |
Trilipix |
Fenofibric Acid |
AbbVie |
Mylan Pharms |
3/25/2013 |
Symbyax |
Olanzapine and Fluoxetine Hydrochloride |
Lilly |
Teva Pharms |
3/25/2013 |
Amnesteem |
Zenatane |
Mylan |
Dr. Reddy's Labs |
3/26/2013 |
Maxalt |
Rizatriptan Benzoate |
Merck |
Cipla |
3/26/2013 |
Xyzal |
Levocetirizine Dihydrochloride |
UCB Inc |
Sandoz |
3/26/2013 |
Lunesta |
Eszopiclone |
Sunovion Pharms Inc |
Mylan Pharms |
3/26/2013 |
Diphenhydramine Hydrochloride |
Diphenhydramine Hydrochloride Preservative Free |
Hikma Maple |
BD RX |
3/27/2013 |
Mirapex |
Pramipexole Dihydrochloride |
Boehringer Ingelheim |
Sun Pharm Indus |
3/27/2013 |
Norco |
Hydrocodone Bitartrate and Acetaminophen |
Watson Labs |
Tris Pharma |
3/27/2013 |
Plavix |
Clopidogrel Bisulfate |
Sanofi Aventis US |
Accord Healthcare |
3/28/2013 |
Exforge |
Amlodipine Besylate and Valsartan |
Novartis |
Par Pharm |
3/28/2013 |
Exforge |
Amlodipine Besylate and Valsartan |
Novartis |
Par Pharm |
3/28/2013 |
Cyproheptadine Hydrochloride |
Cyproheptadine Hydrochloride |
Lyne |
Pharm Assoc |
3/28/2013 |
Micronor |
Norethindrone |
Janssen Pharms |
Lupin Pharms |
3/28/2013 |
Indomethacin |
Indomethacin |
Mylan |
Sun Pharm Indus |
3/28/2013 |
Hydralazine Hydrochloride |
Hydralazine Hydrochloride |
Luitpold |
Navinta |
3/29/2013 |
Zometa |
Zoledronic Acid |
Novartis |
Dr Reddy's Labs |
3/29/2013 |
Ultram |
Tramadol Hydrochloride |
Janssen Pharms |
CSPC OUYI Pharm |
3/29/2013 |
Zometa |
Zoledronic Acid |
Novartis |
Emcure Pharms |