| Approval Date | Reference Listed Drug | Generic Drug Name | NDA Holder | ANDA Applicant |
|---|---|---|---|---|
| 4/4/2016 | Polymyxin B Sulfate | Polymyxin B Sulfate | Eurohealth Intl | Aurobindo Pharma |
| 4/8/2016 | Entocort EC | Budesonide | Perrigo | Actavis |
| 4/8/2016 | Evista | Raloxifene Hydrochloride | Eli Lilly | Amneal |
| 4/11/2016 | Fludeoxyglucose F18 | Fludeoxyglucose F18 | Queen Hamamatsu Pet | Kreitchman Pet Ctr |
| 4/11/2016 | Gemcitabine Hydrochloride | Gemcitabine Hydrochloride | Hospira | Actavis |
| 4/12/2016 | Kadian | Morphine Sulfate | Allergan | Impax Labs |
| 4/12/2016 | Norco | Hydrocodone Bitartrate / Acetaminophen | Watson Labs / Actavis | Rhodes Pharms |
| 4/12/2016 | Aricept | Donepezil Hydrochloride | Eisai | Indicus Pharma |
| 4/12/2016 | Merrem | Meropenem | AstraZeneca | Amneal |
| 4/12/2016 | Temodar | Temozolomide | Merck Sharp Dohme | IDT Australia |
| 4/12/2016 | Roxicodone | Oxycodone Hydrochloride | Mallinckrodt | Ken Lifescience |
| 4/13/2016 | Vfend | Voriconazole | PF Prism CV | Amneal |
| 4/13/2016 | Cordran SP | Flurandrenolide | Aqua Pharms | Teligent Pharma |
| 4/14/2016 | Zyfrel | Hydrocodone Bitartrate / Acetaminophen | Mikart | Cypress Pharm |
| 4/14/2016 | Glyburide | Glyburide | Teva | Pharmadax |
| 4/14/2016 | Polymyxin B Sulfate | Polymyxin B Sulfate | Eurohealth Intl | Gland Pharma |
| 4/15/2016 | Lexiva | Fosamprenavir Calcium | VIIV Healthcare | Mylan |
| 4/15/2016 | Surmontil | Trimipramine Maleate | Odyssey Pharms | Crossmedika |
| 4/19/2016 | Latisse | Bimatoprost | Allergan | Sandoz |
| 4/19/2016 | Indocin | Indomethacin Sodium | Recordati Rare | Hospira |
| 4/19/2016 | Merrem | Meropenem | AstraZeneca | Savior Lifetec |
| 4/20/2016 | Cytomel | Liothyronine Sodium | King Pharms | Sun Pharm |
| 4/21/2016 | Aloxi | Palonosetron Hydrochloride | Helsinn Healthcare | Dr. Reddys Labs |
| 4/21/2016 | Mirapex ER | Pramipexole Dihydrochloride | Boehringer Ingelheim | Actavis |
| 4/21/2016 | Nexium | Esomeprazole Magnesium | AstraZeneca | Aurobindo Pharma |
| 4/22/2016 | Xalatan | Latanoprost | Pharmacia and Upjohn | FDC |
| 4/22/2016 | Savella | Milnacipran Hydrochloride | Cypress Bioscience | Amneal |
| 4/22/2016 | Micardis | Telmisartan | Boehringer Ingelheim | Hetero Labs |
| 4/25/2016 | Derma-Smoothe/FS | Fluocinolone Acetonide | Hill Dermac | Lyne |
| 4/25/2016 | Derma-Smoothe/FS | Fluocinolone Acetonide | Hill Dermac | Lyne |
| 4/25/2016 | Dermotic | Fluocinolone Acetonide | Hill Dermac | Lyne |
| 4/25/2016 | Exforge | Amlodipine Besylate / Valsartan | Novartis | Aurobindo Pharma |
| 4/26/2016 | Opana | Oxymorphone Hydrochloride | Endo Pharms | Aurolife Pharma |
| 4/26/2016 | Ortho Tri-Cyclen | Norgestimate / Ethinyl Estradiol | Janssen Pharms | Lupin |
| 4/26/2016 | Pepcid AC (OTC) | Famotidine (OTC) | Johnson and Johnson | Aurobindo Pharma |
| 4/26/2016 | Cortef | Hydrocortisone | Pharmacia and Upjohn | Pharmaceutics Intl |
| 4/27/2016 | Temodar | Temozolomide | Merck Sharp Dohme | Lotus Pharm |
| 4/28/2016 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Akorn | Mylan |
| 4/28/2016 | Vimpat | Lacosamide | UCB | Amneal |
| 4/28/2016 | Vimpat | Lacosamide | UCB | Actavis |
| 4/28/2016 | Vimpat | Lacosamide | UCB | MSN Labs PVT |
| 4/28/2016 | Vimpat | Lacosamide | UCB | Alembic Pharms |
| 4/28/2016 | Vimpat | Lacosamide | UCB | Aurobindo Pharma |
| 4/28/2016 | Vimpat | Lacosamide | UCB | Mylan |
| 4/28/2016 | Vimpat | Lacosamide | UCB | Sun Pharma |
| 4/28/2016 | Solaraze | Diclofenac Sodium | Fougera Pharms | Taro |
| 4/29/2916 | Crestor | Rosuvastatin Calcium | IPR | Watson Labs |
| 4/29/2016 | Glucophage XR | Metformin Hydrochloride | Bristol Myers Squibb | Marksans Pharma |
| 4/29/2016 | Roxicodone | Oxycodone Hydrochloride | Mallinckrodt | Coastal Pharms |
| 4/29/2016 | Rythmol SR | Propafenone Hydrochloride | GlaxoSmithKline | Mylan |
| 4/29/2016 | Vidaza | Azacitidine | Celgene | Mylan |
| 5/2/2016 | Cambia | Diclofenac Potassium | Depomed | Par |
| 5/3/2016 | Lioresal | Baclofen | Saol Theraps Res | Sintetica |
| 5/3/2016 | Camptosar | Irinotecan Hydrochloride | Pfizer | Qilu Pharm Co |
| 5/3/2016 | Furadantin | Nitrofurantoin | Shionogi | Actavis |
| 5/5/2016 | Tricor | Fenofibrate | Abbvie | Aurobindo Pharma |
| 5/5/2016 | Norpramin | Desipramine Hydrochloride | US Pharm Holdings | Indicus Pharma |
| 5/6/2016 | Natazia | Estradiol Valerate / Dienogest | Bayer Healthcare | Watson Labs |
| 5/6/2016 | Dapsone | Dapsone | Jacobus | Nostrum Labs |
| 5/6/2016 | Buphenyl | Sodium Phenylbutyrate | Horizon Pharma | Par |
| 5/10/2016 | Dapsone | Dapsone | Jacobus | North Creek Pharms |
| 5/10/2016 | Nicorette (OTC) | Nicotine Polacrilex (OTC) | GlaxoSmithKline | Actavis |
| 5/10/2016 | Glyburide | Glyburide | Teva | Zydus Pharms USA |
| 5/10/2016 | Topicort | Desoximetasone | Taro | Novel Labs |
| 5/11/2016 | Rythmol | Propafenone Hydrochloride | GlaxoSmithKline | Orion Corp Orion |
| 5/11/2016 | Oxaliplatin | Oxaliplatin | Sun Pharma | Qilu Pharm Co |
| 5/11/2016 | Zovirax | Acyclovir | Valeant Bermuda | Fougera Pharms |
| 5/11/2016 | Zomig | Zolmitriptan | IPR | Aurbindo Pharma |
| 5/12/2016 | Ortho Tri-Cyclen Lo | Norgestimate / Ethinyl Estradiol | Janssen Pharms | Haupt Pharma |
| 5/13/2016 | Triamcinolone Acetonide | Triamcinolone Acetonide | Perrigo | Teligent Pharma |
| 5/13/2016 | Dilaudid | Hydromorphone Hydrochloride | Purdue Pharm | Aurolife Pharma |
| 5/13/2016 | Marcaine | Bupivacaine Hydrochloride | Hospira | Aurobindo Pharma |
| 5/16/2016 | Banzel | Rufinamide | Eisai | Roxane |
| 5/16/2016 | Banzel | Rufinamide | Eisai | Glenmark Pharms |
| 5/16/2016 | Banzel | Rufinamide | Eisai | Mylan |
| 5/16/2016 | Flagyl | Metronidazole | GD Searle | Flamingo Pharms |
| 5/17/2016 | Seroquel | Quetiapine Fumarate | AstraZeneca | Macleods Pharms |
| 5/18/2016 |
Bacteriostatic Sodium
Chloride 0.9% in Plastic
Container / Sodium
Chloride 0.9% Plastic Container
|
Bacteriostatic Sodium
Chloride 0.9% in
Plastic Container /
Sodium Chloride 0.9%
Plastic Container
|
Hospira / Baxter
Healthcare /
Fresenius Kabi
USA / Taro
Pharms Ireland
|
Jubilant Hollistrstr |
| 5/19/2016 | Derma-Smoothe/FS | Fluocinolone Acetonide | Hill Dermac | Taro |
| 5/19/2016 | Sodium Fluoride F-18 | Sodium Fluoride F-18 | Houston Cyclotron | Kreitchman Pet Ctr |
| 5/19/2016 | Lipitor | Atorvastatin Calcium | Pfizer | Sciegen Pharms |
| 5/19/2016 | Treanda | Bendamustine Hydrochloride | Cephalon | Accord Healthcare |
| 5/19/2016 | Derma-Smoothe/FS | Fluocinolone Acetonide | Hill Dermac | Taro Pharm Inds |
| 5/20/2016 | Zomig | Zolmitriptan | IPR | Ajanta Pharma |
| 5/20/2016 | Treanda | Bendamustine Hydrochloride | Cephalon | Hospira |
| 5/23/2016 | Restoril | Temazepam | Mallinckrodt | Amneal Pharms |
| 5/24/2016 | Vfend | Voriconazole | PF Prism CV | Ajanta Pharma |
| 5/24/2016 | Minastrin 24 FE |
norethindrone
acetate / ethinyl estradiol /
ferrous fumarate
|
Apil | Lupin |
| 5/24/2016 | Vfend | Voriconazole | PF Prism CV | Zydus Pharms USA |
| 5/24/2016 | Vfend | Voriconazole | PF Prism CV | Appco Pharma |
| 5/24/2016 | Vfend | Voriconazole | PF Prism CV | Novel Labs |
| 5/26/2016 | Cleocin | Clindamycin Palmitate Hydrochloride | Pharmacia and Upjohn | Mylan |
| 5/27/2016 | Robaxin | Methocarbamol | Eurohealth Intl | Aurbindo Pharma |
| 5/31/2016 | Lo Loestrin FE |
Norethindrone
Acetate / Ethinyl
Estradiol / Ethinyl
Estradiol / Ferrous
Fumarate
|
Apil | Jai Pharma |
| 5/31/2016 | Vfend | Voriconazole | PF Prism CV | Novel Labs |
| 5/31/2016 | Amantadine Hydrochloride | Amantadine Hydrochloride | Sandoz | Zydus Pharms USA |
| 6/1/2016 | Prevacid 24 Hr (OTC) | Lansoprazole (OTC) | Novartis | Mylan |
| 6/2/2016 | Vicoprofen |
Hydrocodone
Bitartrate / Ibuprofen
|
Abbvie | Aurolife Pharma |
| 6/2/2016 | Hydrocodone Bitartrate / Acetaminophen |
Hydrocodone
Bitartrate / Acetaminophen
|
Mikart | Actavis |
| 6/2/2016 | Keppra | Levetiracetam | UCB | Jubilant Life |
| 6/3/2016 | Leribane |
Norethindrone
Acetate / Ethinyl
Estradiol
|
Barr Labs | Novast Labs |
| 6/3/2016 | Femara | Letrozole | Novartis | Hikma Pharms |
| 6/3/2016 | Cordarone |
Amiodarone
Hydrochloride
|
Wyeth | Aurobindo Pharma |
| 6/6/2016 | Keppra XR | Levetiracetam | UCB | Lotus Pharm Co |
| 6/6/2016 | Tikosyn | Dofetilide | Pfizer | Tiger Pharms |
| 6/7/2016 | Eloxatin | Oxaliplatin | Sanofi Aventis US / Teva | Qilu Pharm Co |
| 6/8/2016 | Merrem | Meropenem | AstraZeneca | Gland Pharma |
| 6/9/2016 | Zantac | Ranitidine Hydrochloride | IGI Labs | Mylan |
| 6/9/2016 | Merrem | Meropenem | AstraZeneca | Par |
| 6/9/2016 | Emend | Fosaprepitant Dimeglumine | Merck | Fresenius Kabi USA |
| 6/9/2016 | Cyklokapron | Tranexamic Acid | Pharmacia and Upjohn | Akorn |
| 6/10/2016 | Sprycel | Dasatinib | Bristol Myers Squibb | Apotex |
| 6/10/2016 | Neomycin Sulfate | Neomycin Sulfate | Teva | Lannett Holdings |
| 6/10/2016 | Paxil CR |
Paroxetine
Hydrochloride
|
Apotex | Kremers Urban Pharms |
| 6/10/2016 | Heparin Sodium | Heparin Sodium | Eurohealth Intl / Fresenius Kabi USA | Fresenius Kabi USA |
| 6/13/2016 | Minocycline Hydrochloride |
Minocycline
Hydrochloride
|
Sandoz | Aurobindo Pharma |
| 6/13/2016 | Ofirmev | Acetaminophen | Mallinckrodt | Paddock |
| 6/14/2016 | Precedex |
Dexmedetomidine
Hydrochloride
|
Hospira | Sandoz |
| 6/14/2016 | Avodart | Dutasteride | GlaxoSmithKline | Mylan |
| 6/14/2016 | Avapro | Irbesartan | Sanofi Aventis | Hisun Pharm Hangzhou |
| 6/15/2016 | Norco |
Hydrocodone
Bitartrate /
Acetaminophen
|
Watson Labs / Actavis | Larken Labs |
| 6/15/2016 | Buphenyl |
Sodium
Phenylbutyrate
|
Horizon Pharma | Par |
| 6/15/2016 | Cubicin | Daptomycin | Cubist | Crane Pharms |
| 6/16/2016 | Fusilev | Levoleucovorin Calcium | Spectrum Pharms | Eurohlth Intl |
| 6/17/2016 | Lopid | Gemfibrozil | Pfizer Pharms | Cadila Pharms |
| 6/17/2016 | Abilify | Aripiprazole | Otsuka | Amneal |
| 6/17/2016 | Lamictal ODT | Lamotrigine | GlaxoSmithKline | Sciegen Pharms |
| 6/20/2016 | Robinul / Robinul Forte | Glycopyrrolate | Casper Pharma | Natco Pharma |
| 6/20/2016 | Activella | Amabelz | Amneal | Lupin |
| 6/20/2016 | Revatio | Sildenafil Citrate | Pfizer | Rubicon Res |
| 6/21/2016 |
Advil Liqui-Gels /
Advil Migraine Liqui-
Gels (OTC)
|
Ibuprofen (OTC) | Pfizer | Puracap Pharm |
| 6/23/2016 | MS Contin | Morphine Sulfate | Purdue Pharma | Corepharma |
| 6/23/2016 | Aricept | Donepezil Hydrochloride | Eisai | Unichem Labs |
| 6/23/2016 | Fenoglide | Fenofibrate | Santarus | Mylan |
| 6/23/2016 | Primaquine | Primaquine Phosphate | Sanofi Aventis | Ingenius Pharms |
| 6/23/2016 | Nystatin / Triamcinolone Acetonide |
Nystatin /
Triamcinolone Acetonide
|
Taro | Glenmark Pharms |
| 6/23/2016 | Differin | Adapalene | Galderma Labs | Taro |
| 6/24/2016 | Mirapex ER | Pramipexole Dihydrochloride | Boehringer Ingelheim | Macleods Pharms |
| 6/24/2016 | Diazepam | Diazepam | Roxane | Lannett Holdings |
| 6/27/2016 | Vibramcycin | Doxycycline Hyclate | Pfizer | Amneal |
| 6/29/2016 | Naloxone Hydrochloride | Naloxone Hydrochloride | Hospira | Mylan |
