This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA.
| Approval Date | Reference Listed Drug | Generic Drug Name | NDA Holder | ANDA Applicant |
|---|---|---|---|---|
| 01/02/2020 | Canasa | Mesalamine | Allergan | Amneal |
| 01/02/2020 | Jadenu | Deferasirox | Novartis | Sun Pharm |
| 01/03/2020 | Exjade | Deferasirox | Novartis | Ichnos |
| 01/03/2020 | Tracleer | Bosentan | Actelion | Cipla |
| 01/03/2020 | Anexsia 5/325 | Hydrocodone Bitartrate / Acetaminophen | SpecGx | Granules Pharms |
| 01/06/2020 | Enablex | Darifenacin Hydrobromide | Allergan | Polygen Pharms |
| 01/06/2020 | Inderal LA | Propranolol HCl | ANI Pharma | Amta |
| 01/07/2020 | D.H.E. 45 | Dihydroergotamine Mesylate | Bausch & Lomb | Apollo |
| 01/08/2020 | Haldol | Haloperidol | Ortho McNeil | Appco |
| 01/08/2020 | Nicorette | Nicotine Polacrilex | GlaxoSmithKline | Dr Reddys |
| 01/09/2020 | Mestinon | Pyridostigmine Bromide | Bausch & Lomb | Invatech |
| 01/09/2020 | Lavaza | Omega-3-Acid Ethyl Esters | Glaxo | Sun Pharm |
| 01/10/2020 | Viibryd | Vilazodone HCl | Allergan | Alembic Pharms |
| 01/10/2020 | Tepadina | Thiotepa | Amneal | Sti Pharma |
| 01/10/2020 | Lyrica | Pregabalin | Pfizer | Cipla |
| 01/10/2020 | Mestinon | Pyridostigmine Bromide | Bausch & Lomb | Amneal |
| 01/13/2020 | Valcyte | Valganciclovir HCl | Roche | Ajanta Pharma |
| 01/13/2020 | Zanaflex | Tizanidine HCl | Covis | Alembic Pharms |
| 01/14/2020 | Cyklokapron | Tranexamic Acid | Pharmacia & Upjohn | Apotex |
| 01/14/2020 | Urocit K | Potassium Citrate | Mission | Ani Pharms |
| 01/15/2020 | Tracleer | Bosentan | Actelion | Mylan |
| 01/15/2020 | Anectine / Quelicin | Succinylcholine Chloride | Sandoz / Hospira | Somerset Theraps |
| 01/15/2020 | Claritin | Loratadine | Bayer | Strides Pharma |
| 01/16/2020 | Wellbutrin | Bupropion HCl | GlaxoSmithKline | Cadila Pharms |
| 01/16/2020 | Vazculep | Phenylephrine HCL | Avadel | Riconpharma |
| 01/17/2020 | Narcan | Naloxone HCl | Adapt | Par Sterile Products |
| 01/17/2020 | Tricor | Fenofibrate | AbbVie | Alembic Pharms |
| 01/17/2020 | Thorazine | Chlorpromazine HCl | GlaxoSmithKline | Zydus |
| 01/21/2020 | Zohydro ER | Hydrocodone Bitartrate | Persion | Alvogen |
| 01/21/2020 | Latisse | Bimatoprost | Allergan | Alembic Pharms |
| 01/22/2020 | Xenazine | Tetrabenazine | Bausch & Lomb | Piramal |
| 01/23/2020 | Tracleer | Bosentan | Actelion | Alembic Pharms |
| 01/24/2020 | Detrol | Tolterodine Tartrate | Pharmacia & Upjohn | Unique Pharm Labs |
| 01/24/2020 | Yasmin | Drospirenone / Ethinyl Estradiol | Bayer | Hetero Labs |
| 01/24/2020 | Methotrexate Sodium | Methotrexate Sodium | Dava | Accord Healthcare |
| 01/27/2020 | Voltaren 1% | Diclofenac Sodium | GlaxoSmithKline | Encube |
| 01/27/2020 | Zithromax | Azithromycin | Pfizer | Alembic Pharms |
| 01/27/2020 | Oxycodone HCl | Oxycodone HCl | Genus Life | Aurolife Pharma |
| 01/27/2020 | Cormax | Clobetasol Propionate | Hi Tech | Aleor Dermaceuticals |
| 01/28/2020 | Patanase | Olopatadine HCl | Novartis | Amneal |
| 01/28/2020 | Zithromax | Azithromycin | Pfizer | Alembic Pharms |
| 01/29/2020 | Tikosyn | Dofetilide | Pfizer | MSN |
| 01/30/2020 | Precedex | Dexmedetomidine HCl | Hospira | Hikma |
| 01/30/2020 | Methotrexate Sodium | Methotrexate Sodium | Dava | Eugia Pharma |
| 01/31/2020 | Onfi | Clobazam | Lundbeck | Teva |
| 01/31/2020 | Valcyte | Valganciclovir HCl | Roche | Granules Pharms |
| 02/03/2020 | Calcijex | Calcitriol | AbbVie | Gland Pharma |
| 02/04/2020 | Arava | Leflunomide | Sanofi | Lupin |
| 02/04/2020 | Evekeo | Amphetamine Sulfate | Arbor | Cerovene |
| 02/05/2020 | Desyrel | Trazodone HCl | Pragma | Aurolife Pharma |
| 02/05/2020 | Hicon | Sodium Iodide I 131 | Jubilant DraxImage | Intl Isotopes |
| 02/05/2020 | Colcrys | Colchicine | Takeda | Granules Pharms |
| 02/06/2020 | Technescan Mag3 | Technetium TC99M Mertiatide Kit | Curium | Sommer Pharms |
| 02/06/2020 | Fludeoxyglucose F-18 | Fludeoxyglucose F18 | Feinstein Institute | Univ Texas SW Med Ctr |
| 02/07/2020 | Marinol | Dronabinol | Alkem | Ascent Pharms |
| 02/07/2020 | Anafranil | Clomipramine HCl | SpecGx | Leading Pharma |
| 02/07/2020 | Faslodex | Fulvestrant | Astra-Zeneca | Chia Tai Tianqing |
| 02/07/2020 | Hectorol | Doxercalciferol | Sanofi Genzyme | Meitheal |
| 02/07/2020 | Norco | Hydrocodone Bitartrate / Acetaminophen | Teva | Xiromed |
| 02/10/2020 | Vanos | Fluocinonide | Bausch | Cadila |
| 02/11/2020 | Exjade | Deferasirox | Novartis | Cipla |
| 02/11/2020 | Hygroton | Chlorthalidone | Sanofi Aventis | Alkem Labs |
| 02/12/2020 | Canasa | Mesalamine | Allergan | Zydus Pharms |
| 02/12/2020 | Ranexa | Ranolazine | Gilead | Mankind Pharma |
| 02/12/2020 | Actigall | Ursodiol | Allergan | Rising |
| 02/13/2020 | Depen | Penicillamine | Mylan | Teva |
| 02/14/2020 | Rapaflo | Silodosin | Allergan | Hetero Labs |
| 02/14/2020 | DDAVP | Desmopressin Acetate | Ferring | UBI |
| 02/18/2020 | Vimovo | Naproxen / Esomeprazole Magnesium | Horizon | Dr Reddys |
| 02/18/2020 | Evomela | Melphalan HCl | Acrotech | Ingenus Pharms |
| 02/18/2020 | Singulair | Montelukast Sodium | Merck | Aurobindo |
| 02/19/2020 | Arthrotec | Diclofenac Sodium / Misoprostol | Pfizer | Yung Shin Pharm |
| 02/19/2020 | Pazeo | Olopatadine Hydrochloride | Novartis | Watson |
| 02/19/2020 | Zometa | Zoledronic Acid | Novartis | Ingenus Pharms |
| 02/19/2020 | Edecrin | Ethacrynic Acid | Bausch & Lomb | Upsher Smith |
| 02/20/2020 | Syprine | Trientine HCl | Bausch & Lomb | Rising |
| 02/20/2020 | Lomotil | Diphenoxylate HCl / Atropine Sulfate | GD Searle | Leading Pharma |
| 02/21/2020 | Robinul | Glycopyrrolate | Hikma | Riconpharma |
| 02/21/2020 | PhosLo GelCaps | Calcium Acetate | Fresenius | Suven Life |
| 02/21/2020 | Naprosyn | Naproxen | Atnahs | Sciegen Pharms |
| 02/21/2020 | Nicorette | Nicotine Polacrilex | Glaxo | Dr Reddys |
| 02/24/2020 | ProAir HFA | Albuterol Sulfate | Teva | Perrigo |
| 02/24/2020 | Onfi | Clobazam | Lundbeck | Hetero Labs |
| 02/24/2020 | Heparin Sodium | Heparin Sodium | Fresenius Kabi | Nanjing King-Friend |
| 02/24/2020 | Allegra Allergy | Fexofenadine HCl | Sanofi | Perrigo |
| 02/25/2020 | Celebrex | Celecoxib | GD Searle | Tianjin Tianyao |
| 02/25/2020 | Astelin | Azelastine HCl | Meda | Gland Pharma |
| 02/26/2020 | Amicar | Aminocaproic Acid | Clover | Vistapharm |
| 02/27/2020 | Ranexa | Ranolazine | Gilead | Micro Labs |
| 02/28/2020 | Namenda XR | Memantine HCl | Allergan | Ani Pharms |
| 02/28/2020 | Daraprim | Pyrimethamine | Turing | Cerovene |
| 02/28/2020 | Namenda | Memantine HCl | Allergan | Hikma Pharms |
| 02/28/2020 | Aubagio | Teriflunomide | Sanofi | Mylan |
| 02/28/2020 | Migranal | Dihydroergotamine Mesylate | Bausch & Lomb | Custopharm |
| 02/28/2020 | Truvada | Emtricitabine / Tenofovir Disoproxil Fumarate | Gilead | Zydus Pharms |
| 02/28/2020 | Depakote | Divalproex Sodium | AbbVie | Ajanta Pharma |
| 03/02/2020 | Viagra | Sildenafil Citrate | Pfizer | Appco |
| 03/02/2020 | Symmetrel | Amantadine HCl | Endo | Invatech |
| 03/03/2020 | Riomet | Metformin HCl | Sun | Saptalis Pharms |
| 03/03/2020 | Achromycin V | Tetracycline HCl | Avet Pharma | Strides Pharma |
| 03/04/2020 | Topicort | Desoximetasone | Taro | Cosette |
| 03/04/2020 | Periostat | Doxycycline Hyclate | Galderma | Alembic Pharms |
| 03/04/2020 | Westcort | Hydrocortisone Valerate | Sun | Cosette |
| 03/04/2020 | Klor-Con | Potassium Chloride | Upsher-Smith | Granules Pharms |
| 03/04/2020 | Tamiflu | Oseltamivir Phosphate | Gilead | Sunshine Lake |
| 03/04/2020 | Tepadina | Thiotepa | Amneal | MSN |
| 03/06/2020 | Kytril | Granisetron HCl | Hoffman La Roche | Yung Shin Pharm |
| 03/06/2020 | Evomela | Melphalan HCl | Acrotech | Actavis |
| 03/06/2020 | Celebrex | Celecoxib | GD Searle | Yiling Pharm |
| 03/09/2020 | Firazyr | Icatibant Acetate | Takeda | Jiangsu Hansoh Pharm |
| 03/10/2020 | Staxyn | Vardenafil HCl | Bayer | Macleods |
| 03/10/2020 | Symmetrel | Amantadine HCl | Endo | Invatech |
| 03/11/2020 | PediaPred | Prednisolone Sodium Phosphate | Seton Pharma | Pharm Assoc |
| 03/11/2020 | Pradaxa | Dabigatran Etexilate Mesylate | BI | Alkem Labs |
| 03/11/2020 | Evoclin | Clindamycin Phosphate | Mylan | Taro Pharm |
| 03/11/2020 | Evekeo | Amphetamine Sulfate | Arbor | Prinston |
| 03/12/2020 | Effexor XR | Venlafaxine HCl | Pfizer | Inventia Healthcare |
| 03/16/2020 | Methadose | Methadone HCl | SpecGx | Vistapharm |
| 03/16/2020 | Kyprolis | Carfilzomib | Bayer | Apotex |
| 03/16/2020 | Zarontin | Ethosuximide | Pfizer | Puracap Pharm |
| 03/16/2020 | Vibra-Tabs | Doxycycline Hyclate | Pfizer | Oaklock |
| 03/16/2020 | Xylocaine | Lidocaine | Astra-Zeneca | Macleods |
| 03/16/2020 | Narcan | Naloxone HCl | Adapt | Dr Reddys |
| 03/17/2020 | Xenazine | Tetrabenazine | Bausch | Apotex |
| 03/17/2020 | Bromday | Bromfenac Sodium | Bausch | Gland Pharma |
| 03/17/2020 | Isoptin | Verapamil HCl | Mt. Adams Technologies | Areva Pharms |
| 03/18/2020 | Valtrex | Valacyclovir HCl | GlaxoSmithKline | Yiling Pharm |
| 03/18/2020 | Tricor | Fenofibrate | AbbVie | Graviti Pharms |
| 03/18/2020 | Triamcinolone Acetonide | Triamcinolone Acetonide | Mylan | Strides Pharma |
| 03/19/2020 | Canasa | Mesalamine | Allergan | Annora Pharma |
| 03/20/2020 | Integrelin | Eptifibatide | Merck | Hybio |
| 03/20/2020 | Kyprolis | Carfilzomib | Bayer | Apotex |
| 03/20/2020 | Lyrica | Pregabalin | Pfizer | Celltrion |
| 03/23/2020 | Nexium | Esomeprazole Magnesium | Astra-Zeneca | Cipla |
| 03/23/2020 | Nexium | Esomeprazole Magnesium | Astra-Zeneca | Cipla |
| 03/23/2020 | Ranexa | Ranolazine | Gilead | Sunshine Lake |
| 03/23/2020 | Ranexa | Ranolazine | Gilead | Sungen Pharma |
| 03/23/2020 | Lyrica | Pregabalin | Pfizer | Hikal |
| 03/24/2020 | Focalin | Dexmethylphenidate HCl | Novartis | Bionpharma |
| 03/24/2020 | Primacor | Milrinone Lactate | Sanofi Aventis | Nanjing King-Friend |
| 03/24/2020 | Zanaflex | Tizanidine HCl | Covis | Aurobindo |
| 03/25/2020 | Prilosec OTC | Omeprazole Magnesium | Astra-Zeneca | Hetero Labs |
| 03/25/2020 | Mucinex D | Guaifenesin / Pseudoephedrine HCl | Reckitt Benckiser | Aurobindo |
| 03/25/2020 | Isoptin | Verapamil HCl | Mt. Adams Technologies | Caplin |
| 03/27/2020 | Azasan | Azathioprine | AAIPharma | Alkem Labs |
| 03/27/2020 | Levothyroxine sodium powder | Levothyroxine Sodium | Fresenius-Kabi | Dr Reddys |
| 03/30/2020 | Toprol-XL | Metoprolol Succinate | Toprol Acquisition | Pharmadax |
| 03/30/2020 | Suboxone | Buprenorphine HCl / Naloxone HCl | Indivior | Rhodes Pharms |
| 03/30/2020 | Vigamox | Moxifloxacin HCl | Novartis | Mylan |
| 03/30/2020 | Daliresp | Roflumilast | Astra-Zeneca | Strides Pharma |
| 03/30/2020 | Vigamox | Moxifloxacin HCl | Novartis | Gland Pharma |
| 03/30/2020 | Jadenu | Deferasirox | Novartis | Alkem Labs |
| 03/30/2020 | Methylin | Methylphenidate HCl | SpecGx | Alkem Labs |
| 03/31/2020 | Toprol-XL | Metoprolol Succinate | Toprol Acquisition | Pharmadax |
| 03/31/2020 | Vfend | Voriconazole | PF Prism | Gland Pharma |
| 03/31/2020 | Vibramycin | Doxycycline Hyclate | Pfizer | Zhejiang Yongtai |
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