| Approval Date | Reference Listed Drug | Generic Drug Name | NDA Holder | ANDA Applicant |
|---|---|---|---|---|
| 10/2/2019 | Methadone HCl | Methadone HCl | N/A | Pharm Assoc |
| 10/2/2019 | Temovate | Clobetasol Propionate | Fougera | Aleor Dermaceuticals |
| 10/2/2019 | Temovate | Clobetasol Propionate | Fougera | Saptalis Pharms |
| 10/4/2019 | Azilect | Rasagiline | Teva | Indoco Remedies |
| 10/4/2019 | Gemzar | Gemcitabine HCl | Eli Lilly | Shilpa Medicare |
| 10/4/2019 | Ritalin | Methylphenidate HCl | Novartis | Alkem Labs |
| 10/4/2019 | Lanoxin | Digoxin | Hikma | Vistapharm |
| 10/7/2019 | Cialis | Tadalafil | Eli Lilly | Macleods Pharms |
| 10/7/2019 | Welchol | Colesevelam HCl | Daiichi Sankyo | Zydus Pharms |
| 10/7/2019 | Zovirax | Acyclovir | Mylan | Square Pharms |
| 10/7/2019 | Vibramycin | Doxycycline Hyclate | Pfizer | Changzhou Pharm |
| 10/8/2019 | Lyrica | Pregabalin | Pfizer | Hetero Labs |
| 10/9/2019 | Lymepak | Doxycycline Hyclate | Chartwell Pharma | Changzhou Pharm |
| 10/9/2019 | Anectine / Quelicin | Succinylcholine Chloride | Sandoz / Hospira | Breckenridge |
| 10/11/2019 | Diporlene | Betamethasone Dipropionate | Merck Sharp & Dohme | Hi Tech |
| 10/15/2019 | Uloric | Febuxostat | Takeda | Hikma |
| 10/15/2019 | Narcan | Naloxone HCl | Adapt Pharma | Aurobindo Pharma |
| 10/16/2019 | Adcirca | Tadalafil | Eli Lilly | Macleods Pharms |
| 10/16/2019 | Zytiga | Abiraterone Acetate | Johnson and Johnson | Glenmark Pharms |
| 10/16/2019 | Nexium 24 HR | Esomeprazole Magnesium | Astra-Zeneca | Mylan |
| 10/16/2019 | Bloxiverz | Neostigmine Methylsulfate | Avadel Legacy Pharma | Gland Pharma |
| 10/17/2019 | Diamox | Acetazolamide | Teva | Novitium Pharma |
| 10/17/2019 | Flomax | Tamsulosin HCl | Sanofi Aventis | Anbison Lab |
| 10/17/2019 | Xylocaine | Lidocaine | AstraZeneca | Sungen Pharma |
| 10/18/2019 | Tygacil | Tigecycline | Pfizer | Xellia Pharms Aps |
| 10/18/2019 | Depakote ER | Divalproex Sodium | AbbVie | Lupin Ltd |
| 10/18/2019 | Garamycin | Gentamicin Sulfate | Schering Plough | Teligent Pharma |
| 10/18/2019 | Allegra | Fexofenadine HCl | Sanofi | Granules India |
| 10/18/2019 | Rapamune | Sirolimus | Pfizer | Amneal |
| 10/18/2019 | Diamox | Acetazolamide | Teva | Eywa Pharma |
| 10/21/2019 | Zomig | Zolmitriptan | AstraZeneca | Orchid Healthcare |
| 10/21/2019 | Syprine | Trientine HCl | Bausch | Kadmon Pharms |
| 10/21/2019 | Mucinex | Guaifenesin | Indivior | Aurobindo |
| 10/21/2019 | Lodosyn | Carbidopa | Aton Pharma | Aurobindo |
| 10/21/2019 | Anafril | Clomipramine HCl | SpecGx | Jubilant Cadista |
| 10/21/2019 | Embeline | Clobetasol Propionate | Akorn | Aleor Dermaceuticals |
| 10/22/2019 | Staxyn | Vardenafil HCl | Bayer | Macleods Pharms |
| 10/22/2019 | Enablex | Darifenacin Hydrobromide | Novartis | Alan Labs |
| 10/22/2019 | Haldol | Haloperidol Decanoate | Johnson and Johnson | Zydus Pharms |
| 10/22/2019 | Rapamune | Sirolimus | Pfizer | Apotex |
| 10/23/2019 | Angiomax | Bivalirudin | Sandoz | Shuangcheng |
| 10/23/2019 | Ery-Pred | Erythromycin Ethylsuccinate | Arbor | Par Pharm Inc |
| 10/23/2019 | Desonide | Desonide | Perrigo | Aleor Dermaceuticals |
| 10/23/2019 | Akovaz | Ephedrine Sulfate | Avadel Legacy Pharma | Amneal |
| 10/25/2019 | Embeline | Clobetasol Propionate | Akorn | Torrent |
| 10/29/2019 | Robinul | Glycopyrrolate | Hikma | Apotex |
| 10/29/2019 | Ranexa | Ranolazine | Gilead | Amerigen Pharms |
| 10/30/2019 | Ditropan | Oxybutynin Chloride | Janssen | Novast Labs |
| 10/30/2019 | Onfi | Clobazam | Lundbeck | Lannett |
| 10/30/2019 | Anaprox | Naproxen Sodium | Atnahs Pharma | Sciegen Pharms |
| 10/30/2019 | Capoten | Captopril | Par | Seton Pharms |
| 10/30/2019 | Actigall | Ursodiol | Allergan | Eywa Pharma |
| 10/31/2019 | Nicorette | Nicotine Polacrilex | Glaxo | P and L |
| 10/31/2019 | Effexor XR | Venlafaxine HCl | Wyeth | Dexcel Pharma |
| 10/31/2019 | Nicorette | Nicotine Polacrilex | Glaxo | P and L |
| 10/31/2019 | Nicorette | Nicotine Polacrilex | Glaxo | P and L |
| 10/31/2019 | Percocet | Oxycodone / Acetaminophen | Vintage | Granules Pharms |
| 11/01/2019 | Ammonia N 13 | Ammonia N 13 | Feinstein Institute Medical Research | University of Texas Southwest Medical Center |
| 11/01/2019 | Dotarem | Gadoterate Meglumine | Guerbet LLC | GE Healthcare |
| 11/01/2019 | Eryped | Erythromycin Ethylsuccinate | Arbor | Amneal |
| 11/04/2019 | Crestor | Rosuvastatin Calcium | IPR Pharma | Zhejiang Yongtai |
| 11/04/2019 | Nimbex | Cisatracurium Besylate | AbbVie | Zydus |
| 11/04/2019 | Baraclude | Entecavir | Bristol-Myers Squibb | Yaopharma |
| 11/04/2019 | Narcan | Naloxone HCl | Adapt Pharma | Aurobindo |
| 11/05/2019 | Tarceva | Erlotinib HCl | Genentech | Apotex |
| 11/05/2019 | Tarceva | Erlotinib HCl | Genentech | Natco Pharma |
| 11/05/2019 | Tarceva | Erlotinib HCl | Genentech | Sun Pharm |
| 11/05/2019 | Tarceva | Erlotinib HCl | Genentech | Shilpa Medicare |
| 11/05/2019 | Zyflo CR | Zileuton | Mylan | Lupin |
| 11/06/2019 | Folvite | Folic Acid | Wyeth | Exela Pharma Scs |
| 11/07/2019 | Lipitor | Atorvastatin Calcium | Pfizer | Micro Labs |
| 11/08/2019 | Trusopt | Dorzolamide HCl | Merck | Micro Labs |
| 11/08/2019 | Epiduo Gel 1% | Adapalene / Benzoyl Peroxide | Galderma | Glenmark |
| 11/14/2019 | Hectorol | Doxercalciferol | Sanofi | Sun Pharm |
| 11/14/2019 | Celebrex | Celecoxib | GD Searle | Cadila Pharms |
| 11/14/2019 | Buspar | Buspirone HCl | Bristol-Myers Squibb | Unichem Labs |
| 11/15/2019 | Cubicin | Daptomycin | Merck | Sagent Pharms |
| 11/15/2019 | Temovate | Clobetasol Propionate | Fougera | Encube |
| 11/15/2019 | Deltasone | Prednisone | Pharmacia & Upjohn | Novitium Pharma |
| 11/18/2019 | Caduet | Amlodipine Besylate / Atorvastatin Calcium | Pfizer | Apotex |
| 11/18/2019 | Nystatin / Triamcinolone Acetonide | Nystatin / Triamcinolone Acetonide | N/A | Vitruvias Therap |
| 11/18/2019 | Cardizem | Diltiazem HCl | Bausch | Edenbridge Pharms |
| 11/18/2019 | Camptosar | Irinotecan HCl | Pfizer | Gland Pharma |
| 11/20/2019 | Lexiva | Fosamprenavir Calcium | ViiV | Sun Pharm |
| 11/20/2019 | Apriso | Mesalamine | Salix | Mylan |
| 11/20/2019 | Desonide | Desonide | Perrigo | Zydus |
| 11/20/2019 | Exjade | Deferasirox | Novartis | Sun Pharm |
| 11/20/2019 | Exjade | Deferasirox | Novartis | MSN |
| 11/20/2019 | Exjade | Deferasirox | Novartis | Alembic Pharms |
| 11/20/2019 | Exjade | Deferasirox | Novartis | Alkem Labs Ltd |
| 11/20/2019 | Exjade | Deferasirox | Novartis | Bionpharma |
| 11/20/2019 | Jadenu | Deferasirox | Novartis | MSN |
| 11/20/2019 | Jadenu | Deferasirox | Novartis | Zydus Pharms |
| 11/20/2019 | Jadenu | Deferasirox | Novartis | Alembic Pharms |
| 11/20/2019 | Isordil | Isosorbide Dinitrate | Bausch | Zydus |
| 11/21/2019 | Faslodex | Fulvestrant | AstraZeneca | HBT Labs |
| 11/21/2019 | Tenormin | Atenolol | Alvogen Malta | Unichem Labs |
| 11/22/2019 | Rapaflo | Silodosin | Allergan | Alembic Pharms |
| 11/22/2019 | Evekeo | Amphetamine Sulfate | Arbor | Bionpharma |
| 11/22/2019 | Butalbital / Acetaminophen | Butalbital / Acetaminophen | Mayne Pharma | Granules Pharms |
| 11/25/2019 | Exjade | Deferasirox | Novartis | Teva |
| 11/25/2019 | Isopto Carpine | Pilocarpine HCl | Novartis | Somerset Therapeutics |
| 11/25/2019 | Leustatin | Cladribine | Janssen | Hisun Pharm Hangzhou |
| 11/25/2019 | Glumetza | Metformin HCl | Bausch | Glenmark |
| 11/26/2019 | Exelon | Rivastigmine | Novartis | Breckenridge |
| 11/26/2019 | Amicar | Aminocaproic Acid | Clover Pharma | Amneal |
| 11/26/2019 | Lidex | Fluocinonide | County Line | Chemo Research |
| 11/27/2019 | Celebrex | Celecoxib | GD Searle | Umedica Labs |
| 11/27/2019 | Revatio | Sildenafil Citrate | Pfizer | Amneal |
| 11/27/2019 | Parafon Forte | Chlorzoxazone | Janssen | Novitium Pharma |
| 11/27/2019 | Revatio | Sildenafil Citrate | Pfizer | Alkem Labs |
| 11/27/2019 | Revatio | Sildenafil Citrate | Pfizer | Ajanta Pharma |
| 11/29/2019 | Lyrica | Pregabalin | Pfizer | Sun Pharm |
| 11/29/2019 | Lovenox | Enoxaparin Sodium | Sanofi | Nanjing King-Friend |
| 11/29/2019 | Nitropress | Sodium Nitroprusside | AbbVie | Caplin |
| 11/29/2019 | Kenalog | Triamcinolone Acetonide | Mylan | Encube |
| 12/02/2019 | Carafate | Sucralfate | Allergan | Amneal |
| 12/02/2019 | Sterile Water For Injection | Sterile Water For Injection | Hospira | Medefil |
| 12/03/2019 | Solodyn ER | Minocycline HCl | Bausch | Sun Pharm |
| 12/03/2019 | Zipsor | Diclofenac Potassium | Assertio Therapeutics | Strides Pharma |
| 12/03/2019 | Neurontin | Gabapentin | Parke Davis | Vistapharm |
| 12/03/2019 | Sabril | Vigabatrin | Lundbeck | Invagen Pharms |
| 12/04/2019 | Gilenya | Fingolimod HCl | Novartis | Hec Pharm |
| 12/04/2019 | Gilenya | Fingolimod HCl | Novartis | Biocon |
| 12/04/2019 | Gilenya | Fingolimod HCl | Novartis | Sun Pharm |
| 12/04/2019 | Precedex | Dexmedetomidine HCl | Hospira | Slayback Pharma |
| 12/09/2019 | Rilutek | Riluzole | Covis | Standard Chem Pharm |
| 12/09/2019 | Afinitor | Everolimus | Novartis | Par |
| 12/09/2019 | Sotradecol | Sodium Tetradecyl Sulfate | AH Robins | Custopharm |
| 12/09/2019 | Afinitor | Everolimus | Novartis | Teva |
| 12/10/2019 | Unipen | Nafcillin Sodium | Wyeth | Fresenius Kabi |
| 12/11/2019 | Fluorouracil | Fluorouracil | Spectrum Pharma | Ingenus Pharms |
| 12/11/2019 | NuvaRing | Etonogestrel / Ethinyl Estradiol | Organon | Amneal |
| 12/11/2019 | Vesicare | Solifenacin Succinate | Astellas | Cspc Ouyi |
| 12/11/2019 | Zithromax | Azithromycin | Pfizer | Taro |
| 12/11/2019 | Adderall XR | Dextroamp Saccharate / Amp Aspartate / Dextroamp Sulfate / Amp Sulfate | Shire | SunGen Pharma |
| 12/12/2019 | Mydriacyl | Tropicamide | Alcon Labs | Somerset Therapeutics |
| 12/12/2019 | Primaxin | Imipenem / Cilastatin | Merck | Hq Specialty Pharma |
| 12/12/2019 | Fluorouracil | Fluorouracil | Spectrum Pharma | Ingenus Pharms |
| 12/12/2019 | Bumex | Bumetanide | Validus Pharma | Ceyone |
| 12/13/2019 | Jadenu | Deferasirox | Novartis | Actavis |
| 12/13/2019 | Myfortic | Mycophenolic Acid | Novartis | Concord Biotech |
| 12/13/2019 | Levo-Dromoran | Levorphanol Tartrate | Valeant Pharma | Specgx |
| 12/13/2019 | Capoten | Captopril | Par | Ajanta Pharma |
| 12/16/2019 | Zyflo CR | Zileuton | Mylan | Par |
| 12/16/2019 | Cafcit | Caffeine Citrate | Hikma | Micro Labs |
| 12/17/2019 | Ditropoan XL | Oxybutynin Chloride | Janssen | Bionpharma |
| 12/17/2019 | Butalbital / Acetaminophen / Caffeine | Butalbital / Acetaminophen / Caffeine | Nexgen Pharma | Mayne Pharma |
| 12/17/2019 | Tikosyn | Dofetilide | Pfizer | Prinston |
| 12/17/2019 | Butalbital / Acetaminophen / Caffeine | Butalbital / Acetaminophen / Caffeine | Nexgen Pharma | Lannett |
| 12/17/2019 | Butalbital / Acetaminophen / Caffeine | Butalbital / Acetaminophen / Caffeine | Mayne Pharma | Lannett |
| 12/18/2019 | Diprolene | Betamethasone Dipropionate | Merck | Lupin |
| 12/19/2019 | Solodyn ER | Minocycline HCl | Bausch | Alkem Labs |
| 12/19/2019 | Entereg | Alvimopan | Merck | Teva |
| 12/20/2019 | Travatan | Travoprost | Novartis | Alembic Pharms |
| 12/20/2019 | Proglycem | Diazoxide | Teva | E5 Pharma |
| 12/20/2019 | Dextrose / Sodium Chloride in Plastic Container | Dextrose / Sodium Chloride in Plastic Container | Baxter Healthcare | Fresenius Kabi |
| 12/23/2019 | Eliquis | Apixaban | Bristol-Myers Squibb | Micro Labs |
| 12/23/2019 | Eliquis | Apixaban | Bristol-Myers Squibb | Mylan |
| 12/23/2019 | Claritin | Loratadine | Bayer | Granules |
| 12/23/2019 | Cuprimine | Penicillamine | Mylan | Par |
| 12/23/2019 | Cytarabine | Cytarabine | Teva | Gland Pharma |
| 12/26/2019 | Tobi | Tobramycin | Novartis | Sun Pharm |
| 12/26/2019 | Lyrica | Pregabalin | Pfizer | Cspc Ouyi |
| 12/26/2019 | Geodon | Ziprasidone Mesylate | Pfizer | Gland Pharma |
| 12/26/2019 | Valium | Diazepam | Hoffman La Roche | Beloteca |
| 12/26/2019 | Abilify | Aripiprazole | Bristol-Myers Squibb | Vistapharm |
| 12/27/2019 | Myrbetriq | Mirabegron | Astellas | Sawai |
| 12/27/2019 | Jadenu | Deferasirox | Novartis | Amneal |
| 12/27/2019 | Tikosyn | Dofetilide | Pfizer | Riconpharma |
| 12/30/2019 | Uloric | Febuxostat | Takeda | Indoco Remedies |
| 12/30/2019 | Uloric | Febuxostat | Takeda | MSN |
| 12/30/2019 | Detrol | Tolterodine Tartrate | Pfizer | Invatech |
| 12/30/2019 | Cormax | Clobetasol Propionate | Akorn | Torrent |
| 12/30/2019 | Marcaine | Bupivacaine HCl | Hospira | Huons |
| 12/30/2019 | Jadenu | Deferasirox | Novartis | Piramal |