| 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 |
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ANDA Approvals
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