Approval Date |
Reference Listed Drug |
Generic Drug Name |
NDA Holder |
ANDA Applicant |
1/2/2019 |
Mirapex ER |
Pramipexole Dihydrochloride |
Boehringer Ingelheim |
Alembic Pharms |
1/3/2019 |
Latuda |
Lurasidone HCl |
Sunovion |
Amneal |
1/3/2019 |
Latuda |
Lurasidone HCl |
Sunovion |
Invagen Pharms |
1/3/2019 |
Latuda |
Lurasidone HCl |
Sunovion |
Lupin |
1/3/2019 |
Latuda |
Lurasidone HCl |
Sunovion |
Accord Hlthcare |
1/3/2019 |
Aubagio |
Teriflunomide |
Sanofi Aventis |
Sandoz |
1/3/2019 |
Dolophine |
Methadone HCl |
West-Ward Pharms |
Ascent Pharms |
1/4/2019 |
Naproxen Sodium |
Naproxen Sodium (OTC) |
Bionpharma |
Catalent |
1/4/2019 |
Latuda |
Lurasidone HCl |
Sunovion |
Sun Pharma |
1/4/2019 |
Rythmol SR |
Propafenone HCl |
GlaxoSmithKline |
Sinotherapeutics |
1/7/2018 |
Abilify |
Aripiprazole |
Otsuka |
Zydus |
1/7/2018 |
Zytiga |
Abiraterone Acetate |
Janssen |
Amneal |
1/7/2018 |
Picato |
Ingenol Mebutate |
Leo Labs |
Perrigo UK Finco |
1/7/2018 |
Aubagio |
Teriflunomide |
Sanofi Aventis |
Accord Healthcare |
1/8/2019 |
Exelon |
Rivastigmine |
Novartis |
Amneal |
1/8/2019 |
CellCept |
Mycophenolate Mofetil |
Roche |
Concord Biotech |
1/9/2019 |
Picato |
Ingenol Mebutate |
Leo Labs |
Perrigo |
1/9/2019 |
Medrol |
Methylprednisolone |
Pharmacia and Upjohn |
RiconPharma |
1/10/2019 |
Benicar |
Olmesartan Medoxomil |
Daiichi Sankyo |
Qilu Pharm |
1/10/2019 |
Fluoxetine HCl |
Fluoxetine HCl |
Alvogen |
Sciegen |
1/11/2019 |
Caduet |
Amlodipine Besylate / Atorvastatin Calcium |
Pfizer |
Zydus |
1/11/2019 |
Betamethasone Dipropionate |
Betamethasone Dipropionate |
Fougera |
Zydus |
1/11/2019 |
Zovirax |
Acyclovir |
Bausch & Lomb |
Torrent |
1/11/2019 |
Femara |
Letrozole |
Novartis |
Eugia Pharma |
1/14/2019 |
Viramune |
Nevirapine |
Boehringer Ingelheim |
MacLeods |
1/14/2019 |
Microzide |
Hydrochlorothiazide |
Allergan Sales |
Sciegen |
1/14/2019 |
Busulfex |
Busulfan |
Otsuka |
Nexus Pharms |
1/14/2019 |
Lotronex |
Alosetron HCl |
Sebela |
Rising Pharms |
1/14/2019 |
Sabril |
Vigabatrin |
Lundbeck |
Teva |
1/15/2019 |
Relpax |
Eletriptan Hydrobromide |
Pfizer |
Aurobindo |
1/15/2019 |
Plaquenil |
Hydroxychloroquine Sulfate |
Concordia Pharms |
Laurus Labs |
1/16/2019 |
Diamox |
Acetazolamide |
Teva |
Xylopia |
1/16/2019 |
Effient |
Prasugrel |
Eli Lilly and Co |
HEC Pharm |
1/16/2019 |
Syprine |
Trientine HCl |
Aton |
Navinta |
1/17/2019 |
Gleevec |
Imatinib Mesylate |
Novartis |
Shilpa Medicare |
1/17/2019 |
Gleevec |
Imatinib Mesylate |
Novartis |
Wockhardt |
1/18/2019 |
Precedex |
Dexmedetomidine HCl |
Hospira |
Cipla |
1/18/2019 |
Prevacid |
Lansoprazole |
Takeda |
Alkem Labs |
1/18/2019 |
Levo-T / Synthroid / Thyro-Tabs/ Unithroid |
Levothyroxine Sodium |
Cediprof / AbbVie / Lloyd / Stevens |
Lupin |
1/18/2019 |
Cyclophosphamide |
Cyclophosphamide |
West-Ward Pharms |
Cipla |
1/18/2019 |
Zovirax |
Acyclovir |
Bausch & Lomb |
Cipla |
1/22/2019 |
Adderall XR |
Dextroamp Saccharate / AMP Aspartate / Dextroamp Sulfate / AMP Sulfate |
Shire |
Amerigen Pharms |
1/22/2019 |
Klor-Con |
Potassium Chloride |
Upsher-Smith Labs |
PII |
1/22/2019 |
Tikosyn |
Dofetilde |
Pfizer |
Aurobindo |
1/22/2019 |
Retin-A |
Tretinoin |
Valeant |
Taro Pharms |
1/23/2019 |
Brilinta |
Ticagrelor |
AstraZeneca |
Amneal |
1/23/2019 |
Brilinta |
Ticagrelor |
AstraZeneca |
Hisun Pharm Hangzhou |
1/24/2019 |
Trusopt |
Dorzolamide HCl |
Merck |
FDC |
1/24/2019 |
Suboxone |
Buprenorphine HCl / Naloxone HCl |
Indivior |
Alvogen Pine Brook |
1/25/2019 |
Aleve PM |
Naproxen Sodium / Diphenhydramine Chloride |
Bayer Healthcare |
Actavis |
1/25/2019 |
Integrilin |
Eptifibatide |
Schering |
Hainan Poly Pharm |
1/25/2019 |
Bentyl |
Dicyclomine HCl |
Allergan |
Fresenius Kabi |
1/25/2019 |
Depo-Provera |
Medroxyprogesterone Acetate |
Pharmacia and Upjohn |
Cipla |
1/25/2019 |
Retin-A |
Tretinoin |
Valeant |
Taro Pharms |
1/25/2019 |
Fluoxetine Hydrochloride |
Fluoxetine Hydrochloride |
Alvogen |
Dr Reddy's Labs |
1/25/2019 |
Zanaflex |
Tizanidine HCl |
Covis Pharma |
Alkem Labs |
1/25/2019 |
Lialda |
Mesalamine |
Shire |
Sun Pharm |
1/28/2019 |
Lactated Ringer's in Plastic Container |
Sodium Chloride / Sodium Lactate / Potssium Chloride / Calcium Chloride in Water |
Baxter Healthcare |
Fresenius Kabi |
1/28/2019 |
Cleocin T |
Clindamycin Phosphate |
Pharmacia and Upjohn |
Encube Ethicals |
1/28/2019 |
DDAVP |
Desmopressin Acetate |
Ferring Pharms |
Abhai |
1/28/2019 |
Wellbutrin XL |
Bupropion HCl |
Valeant |
Graviti Pharms |
1/28/2019 |
Rapamune |
Sirolimus |
PF Prism |
Novitium Pharma |
1/29/2019 |
Vazculep |
Phenylephrine HCl |
West-Ward Pharm / Avadel Legacy |
Fresenius Kabi |
1/30/2019 |
Advair |
Wixela Inhub |
Glaxo |
Mylan |
1/30/2019 |
Vazculep |
Phenylephrine HCl |
Avadel Legacy |
Fresenius Kabi |
1/30/2019 |
Desonide |
Desonide |
Perrigo |
Encube Ethicals |
1/30/2019 |
Onfi |
Clobazam |
Lundbeck |
Micro Labs |
1/31/2019 |
Vazculep |
Phenylephrine HCl |
West-Ward Pharm / Avadel Legacy |
Sandoz |
1/31/2019 |
Protopic |
Tacrolimus |
Leo Pharma |
Accord Healthcare |
2/1/2019 |
Bentyl |
Dicyclomine HCl |
Allergan |
Nexus Pharms |
2/1/2019 |
Ritalin |
Methylphenidate HCl |
Novartis |
Cediprof |
2/4/2019 |
Trandate |
Labetalol HCl |
County Line Pharms |
Invatech Pharma |
2/4/2019 |
Zovirax |
Acyclovir |
Bausch & Lomb |
Perrigo |
2/4/2019 |
Fetzima |
Levomilnacipran HCl |
Allergan |
Amneal |
2/4/2019 |
Oxycodone HCl |
Oxycodone HCl |
Genus Lifesciences |
Alkem Labs |
2/5/2019 |
Adcirca |
Tadalafil |
Eli Lilly and Co |
Aurobindo |
2/5/2019 |
Adcirca |
Tadalafil |
Eli Lilly and Co |
Hetero |
2/5/2019 |
Adcirca |
Alyq |
Eli Lilly and Co |
Teva |
2/5/2019 |
Adcirca |
Tadalafil |
Eli Lilly and Co |
Dr Reddy's Labs |
2/5/2019 |
Adcirca |
Tadalafil |
Eli Lilly and Co |
Cipla |
2/5/2019 |
Adcirca |
Tadalafil |
Eli Lilly and Co |
Ajanta Pharma |
2/5/2019 |
Adcirca |
Tadalafil |
Eli Lilly and Co |
Lupin |
2/5/2019 |
Vivelle-Dot |
Estradiol |
Novartis |
Amneal |
2/6/2019 |
Seasonale |
Sylevia |
Teva |
Sun Pharm |
2/7/2019 |
Tegretol-XR |
Carbamazepine |
Novartis |
Zydus |
2/7/2019 |
Nicorette |
Nicotine Polacrilex |
GlaxoSmithKline |
PLD Acquisitions |
2/7/2019 |
Benicar HCT |
Olmesartan Medoxomil / Hydrochlorothiazide |
Daiichi Sankyo |
Accord Healthcare |
2/7/2019 |
Oxycodone HCl |
Oxycodone HCl |
Genus Lifesciences / VistaPharm |
Alkem Labs |
2/8/2019 |
Renagel |
Sevelamer HCl |
Genzyme |
Glenmark |
2/8/2019 |
Gleevec |
Imatinib Mesylate |
Novartis |
Breckenridge |
2/8/2019 |
Gleevec |
Imatinib Mesylate |
Novartis |
Amneal |
2/8/2019 |
Ferriprox |
Deferiprone |
Apopharma |
Taro Pharm |
2/8/2019 |
Syprine |
Trientine HCl |
Aton |
Amneal |
2/8/2019 |
Colcrys |
Colchicine |
Takeda |
Alkem Labs |
2/8/2019 |
Fluoxetine HCl |
Fluoxetine HCl |
Alvogen |
Lupin |
2/8/2019 |
Lipitor |
Atorvastatin Calcium |
Pfizer |
MSN Labs |
2/11/2019 |
Dyazide |
Triamterene and Hydrochlorothiazide |
GlaxoSmithKline |
Zydus |
2/11/2019 |
Omeprazole |
Omeprazole (OTC) |
Dexcel Pharma |
Apotex |
2/11/2019 |
Triamcinolone Acetonide |
Triamcinolone Acetonide |
Mylan |
Strides Pharma |
2/11/2019 |
Bentyl |
Dicyclomine HCl |
Allergan |
Custopharm |
2/12/2019 |
CellCept |
Mycophenolate Mofetil |
Roche |
VistaPharm |
2/13/2019 |
Vigamox |
Moxifloxacin HCl |
Novartis |
Alembic Pharms |
2/13/2019 |
Synalar |
Fluocinolone Acetonide |
Medimetriks Pharms |
Encube Ethicals |
2/14/2019 |
DDAVP |
Desmopressin Acetate |
Ferring |
Luitpold |
2/14/2019 |
Gemcitabine HCl |
Gemcitabine HCl |
Hospira |
Ingenus Pharms |
2/14/2019 |
Advil PM |
Ibuprofen / Diphenhydramine HCl |
Pfizer |
Aurobindo Pharma |
2/15/2019 |
Eloxatin |
Oxaliplatin |
Sanofi Aventis / Teva |
Sun Pharma |
2/15/2019 |
Actonel |
Risedronate Sodium |
Apil |
Hangzhou Binjiang |
2/15/2019 |
Olux |
Clobetasol Propionate |
Mylan |
Glenmark |
2/19/2019 |
Micardis |
Telmisartan |
Boehringer Ingelheim |
Hisun Pharm Hangzhou |
2/19/2019 |
Diamox |
Acetazolamide |
Teva |
Alembic Pharms |
2/19/2019 |
Levo-T / Levoxyl / Synthroid / Unithroid |
Levothyroxine Sodium |
Cediprof / King Pharms / AbbVie / Stevens |
Amneal |
2/19/2019 |
Marcaine |
Bupivacaine HCl |
Hospira |
Novocol Healthcare |
2/19/2019 |
Colcrys |
Colchicine |
Takeda |
Zydus |
2/19/2019 |
Zarontin |
Ethosuximide |
Parke Davis |
Strides |
2/20/2019 |
Zovirax |
Acyclovir |
Bausch & Lomb |
Perrigo |
2/20/2019 |
Nimbex |
Cisatracurium Besylate Preservative Free |
AbbVie |
Somerset Theraps |
2/20/2019 |
Mephyton |
Phytonadione |
Bausch & Lomb |
Zydus |
2/21/2019 |
Rocaltrol |
Calcitriol |
Validus Pharms |
Sun Pharm |
2/21/2019 |
Abilify |
Aripiprazole |
Otsuka |
Alkem Labs |
2/21/2019 |
Aromasin |
Exemestane |
Pharmacia and Upjohn |
Breckenridge |
2/22/2019 |
Niaspan |
Niacin |
AbbVie |
Mylan |
2/22/2019 |
Antivert |
Meclizine HCl |
Casper Pharma |
Indicus Pharma |
2/22/2019 |
Gemzar |
Gemcitabine HCl |
Eli Lilly and Co |
Shilpa Medicare |
2/22/2019 |
Medrol |
Methylprednisolone |
Pharmacia and Upjohn |
Lupin |
2/22/2019 |
Cyklokapron |
Tranexamic Acid |
Pharmacia and Upjohn |
Acic Pharms |
2/22/2019 |
Busulfex |
Busulfan |
Otsuka |
Accord Healthcare |
2/22/2019 |
Benicar |
Olmesartan Medoxomil |
Daiichi Sankyo |
Sunshine Lake |
2/22/2019 |
Tessalon |
Benzonatate |
Pfizer |
Ascent Pharms |
2/22/2019 |
Clolar |
Clofarabine |
Genzyme |
Accord Healthcare |
2/25/2019 |
Flagyl I.V. RTU in Plastic Container / Metro I.V. in Plastic Container / Metronidazole in Plastic Container |
Metronidazole in Plastic Container |
Baxter Healthcare / B Braun / Hospira |
Inforlife |
2/25/2019 |
Lovaza |
Omega-3-Acid Ethyl Esters |
SmithKline Beecham |
Ascent Pharms |
2/25/2019 |
Zytiga |
Abiraterone Acetate |
Janssen |
Rising Pharms |
2/26/2019 |
Zithromax |
Azithromycin |
Pfizer |
Bionpharma |
2/26/2019 |
Zithromax |
Azithromycin |
Pfizer |
Bionpharma |
2/27/2019 |
Zytiga |
Abiraterone Acetate |
Janssen |
Wockhardt |
2/27/2019 |
Vidaza |
Azacitidine |
Celgene |
Lupin |
2/27/2019 |
Tamiflu |
Oseltamivir Phosphate |
Roche |
Teva |
2/28/2019 |
Ditropan XL |
Oxybutynin Chloride |
Janssen |
Ajanta |
3/1/2019 |
Perphenazine |
Perphenazine |
Sandoz |
Rising Pharms |
3/1/2019 |
Crestor |
Rosuvastatin Calcium |
IPR |
Zydus |
3/1/2019 |
Gleevec |
Imatinib Mesylate |
Novartis |
Natco Pharma |
3/1/2019 |
Protonix |
Pantoprazole Sodium |
Wyeth |
Ingenus Pharms |
3/4/2019 |
Micardis HCT |
Telmisartan / Hydrochlorothiazide |
Boehringer Ingelheim |
Glenmark |
3/4/2019 |
Exelon |
Rivastigmine |
Novartis |
Zydus |
3/4/2019 |
Faslodex |
Fulvestrant |
AstraZeneca |
Amneal |
3/5/2019 |
Epivir |
Lamivudine |
ViiV Healthcare |
Mylan |
3/5/2019 |
Bepreve |
Bepotastine Besilate |
Bausch and Lomb |
Apotex |
3/5/2019 |
Nexium 24Hr |
Esomeprazole Magnesium |
AstraZeneca |
Actavis |
3/5/2019 |
Kapvay |
Clonidine HCl |
Concordia Pharms |
Novast Labs |
3/6/2019 |
Lipitor |
Atorvastatin Calcium |
Pfizer |
Lupin |
3/8/2019 |
Tenoretic |
Atenolol and Chlorthalidone |
Alvogen Malta |
Zydus |
3/8/2019 |
Mestinon |
Pyridostigmine Bromide |
Bausch |
Novitium Pharma |
3/11/2019 |
Integrilin |
Eptifibatide |
Schering |
USV |
3/11/2019 |
Micro-K / Micro-K 10 |
Potassium Chloride |
Nesher Pharms |
Zydus |
3/11/2019 |
Ampyra |
Dalfampridine |
Acorda |
Micro Labs |
3/12/2019 |
Diovan |
Valsartan |
Novartis |
Alkem |
3/12/2019 |
Claritin |
Loratadine |
Bayer Healthcare |
Newgen Pharms |
3/12/2019 |
Zanaflex |
Tizanidine HCl |
Covis Pharma |
RiconPharma |
3/12/2019 |
Procardia XL |
Nifedipine |
Pfizer |
Novast Labs |
3/12/2019 |
Zyloprim |
Allopurinol |
Casper Pharma |
Unichem Labs |
3/12/2019 |
Desonide |
Desonide |
Perrigo |
Teligent Pharma |
3/13/2019 |
Yasmin |
Kemeya |
Bayer Healthcare |
Sun Pharm |
3/13/2019 |
Sodium Chloride 3% in Plastic Container |
Sodium Chloride 3% in Plastic Container |
Baxter Healthcare |
Fresenius Kabi |
3/13/2019 |
Children's Zyrtec |
Cetirizine HCl |
J and J Consumer |
Hetero Labs Ltd III |
3/14/2019 |
Integrilin |
Epifibatide |
Schering |
USV |
3/14/2019 |
Lovenox |
Enoxaparin Sodium |
Sanofi Aventis |
Amphastar |
3/15/2019 |
Diovan HCT |
Valsartan / Hydrochlorothiazide |
Novartis |
Zydus |
3/15/2019 |
Zovirax |
Acyclovir |
Bausch |
Zydua |
3/18/2019 |
Bepreve |
Bepotastine Besilate |
Bausch and Lomb |
Micro Labs |
3/18/2019 |
Lidex |
Fluocinonide |
County Line Pharms |
Teligent Pharma |
3/19/2019 |
Invanz |
Ertapenem Sodium |
Merck Sharp Dohme |
Savior Lifetec |
3/19/2019 |
Latuda |
Lurasidone HCl |
Sunovion |
Zydus |
3/20/2019 |
Aggrenox |
Aspirin / Dipyridamole |
Boehringer Ingelheim |
Lannett |
3/20/2019 |
Naftin |
Naftifine HCl |
Sebela |
Tolmar |
3/21/2019 |
Epivir-HBV |
Lamivudine |
GlaxoSmithKline |
Annora |
3/22/2019 |
Tekturna |
Aliskiren Hemifumarate |
Noden Pharma |
Anchen Pharms |
3/22/2019 |
Daliresp |
Roflumilast |
AstraZeneca |
Micro Labs |
3/22/2019 |
Makena Preservative Free |
Hydroxyprogesterone Caproate |
Amag Pharma |
Slayback Pharma |
3/22/2019 |
Yaz |
Drospirenone / Ethinyl Estradiol |
Bayer Healthcare |
Hetero |
3/22/2019 |
Viagra |
Sildenafil Citrate |
Pfizer |
Lupin |
3/25/2019 |
Viagra |
Sildenafil Citrate |
Pfizer |
Mylan |
3/25/2019 |
Nuvigil |
Armodafinil |
Cephalon |
Apotex |
3/26/2019 |
Baraclude |
Entecavir |
Bristol-Myers Squibb |
Mylan |
3/26/2019 |
Cialis |
Tadalafil |
Eli Lilly and Co |
Alembic |
3/26/2019 |
Cialis |
Tadalafil |
Eli Lilly and Co |
Aurobindo |
3/26/2019 |
Cialis |
Tadalafil |
Eli Lilly and Co |
Zydus |
3/26/2019 |
Cialis |
Tadalafil |
Eli Lilly and Co |
Sun Pharm |
3/26/2019 |
Cialis |
Tadalafil |
Eli Lilly and Co |
Accord Healthcare |
3/26/2019 |
Cialis |
Tadalafil |
Eli Lilly and Co |
Unichem Labs |
3/26/2019 |
Cialis |
Tadalafil |
Eli Lilly and Co |
Cipla |
3/26/2019 |
Cialis |
Tadalafil |
Eli Lilly and Co |
Ajanta |
3/26/2019 |
Cialis |
Tadalafil |
Eli Lilly and Co |
Amneal |
3/26/2019 |
Cialis |
Tadalafil |
Eli Lilly and Co |
Hetero |
3/26/2019 |
Cialis |
Tadalafil |
Eli Lilly and Co |
Dr Reddy's Labs |
3/26/2019 |
Cialis |
Tadalafil |
Eli Lilly and Co |
Qilu Pharm |
3/26/2019 |
Cialis |
Tadalafil |
Eli Lilly and Co |
Lupin |
3/26/2019 |
Cialis |
Tadalafil |
Eli Lilly and Co |
Sunshine Lake |
3/26/2019 |
Cialis |
Tadalafil |
Eli Lilly and Co |
Torrent |
3/26/2019 |
Adcirca |
Tadalafil |
Eli Lilly and Co |
Torrent |
3/26/2019 |
Zanaflex |
Tizanidine HCl |
Covis Pharma |
Cadila |
3/27/2019 |
Zanaflex |
Tizanidine HCl |
Covis Pharma |
Alkem Labs |
3/28/2019 |
Letairis |
Ambrisentan |
Gilead |
Watson |
3/28/2019 |
Letairis |
Ambrisentan |
Gilead |
Mylan |
3/28/2019 |
Letairis |
Ambrisentan |
Gilead |
Zydus |
3/28/2019 |
Letairis |
Ambrisentan |
Gilead |
Sun Pharm |
3/28/2019 |
Xyzal Allergy 24Hr |
Levocetirizine Dihydrochloride |
Sanofi Avenits |
Perrigo |
3/29/2019 |
Cialis |
Tadalafil |
Eli Lilly and Co |
Watson |
3/29/2019 |
Azilect |
Rasagiline Mesylate |
Teva |
Micro Labs |
3/29/2019 |
Potassium Chloride |
Potassium Chloride |
Genus Lifesciences |
Pharm Assoc |