New Drug Applications and 505(b)(2) Applications
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 |
|---|---|---|---|---|
| 4/1/2021 | Tobi | Tobramycin | Mylan | Alkem |
| 4/1/2021 | Sinequan | Doxepin HCl | Pfizer | Appco |
| 4/2/2021 | Truvada | Emtricitabine / Tenofovir Disoproxil Fumarate | Gilead | Cipla |
| 4/2/2021 | Namenda XR | Memantine HCl | AbbVie | Yichang Humanwell |
| 4/2/2021 | Kybella | Deoxycholic Acid | Kythera | Slayback |
| 4/2/2021 | Dermotic / Derma-Smooth FS | Fluocinolone Acetonide | Hill | Solaris Pharma |
| 4/5/2021 | Bloxiverz | Neostigmine Methylsulfate | Exela | Meitheal |
| 4/6/2021 | Opsumit | Macitentan | Actellion | Zydus |
| 4/7/2021 | Viibryd | Vilazodone HCl | AbbVie | Invagen Pharms |
| 4/8/2021 | Aggrastat | Tirofiban HCl | Medicure | Gland Pharma |
| 4/8/2021 | Cardene | Nicardipine HCl | Chiesi | Aurobindo |
| 4/8/2021 | Amicar | Aminocaproic Acid | Akorn | Airis Pharma |
| 4/12/2021 | Dacogen | Decitabine | Otsuka | Qilu |
| 4/12/2021 | Absorica | Isotretinoin | Sun | Upsher Smith Labs |
| 4/13/2021 | Lyrica CR | Pregabalin | Pfizer | Alvogen Pine Brook |
| 4/13/2021 | Lyrica CR | Pregabalin | Pfizer | Sun Pharm |
| 4/13/2021 | Lyrica CR | Pregabalin | Pfizer | Mylan |
| 4/13/2021 | Lyrica CR | Pregabalin | Pfizer | MSN |
| 4/13/2021 | Lyrica CR | Pregabalin | Pfizer | Apotex |
| 4/13/2021 | Tegretol XR | Carbamazepine | Novartis | CSPC Ouyi |
| 4/14/2021 | Pulmicort Respules | Budesonide | Sun | Sun Pharm |
| 4/14/2021 | Miralax | Polyethylene Glycol 3350 | Bayer | Annora Pharma |
| 4/15/2021 | Acetadote | Acetylcysteine | Exela | Exela Pharma |
| 4/16/2021 | Glumetza | Metformin HCl | Bausch & Lomb | Sciegen Pharms |
| 4/16/2021 | Primacor | Milrinone Lactate | Sanofi Aventis | Caplin |
| 4/20/2021 | Solu Medrol | Methylprednisolone Sodium Succinate | Pfizer | Tianjin Kingyork |
| 4/20/2021 | Xylocaine | Lidocaine | AstraZeneca | Quagen |
| 4/20/2021 | Bloxiverz | Neostigmine Methylsulfate | Exela | Caplin |
| 4/20/2021 | Pepcid | Famotidine | Salix | Novitium Pharma |
| 4/21/2021 | Xyzal | Levocetirizine HCl | Sanofi Aventis | Apotex |
| 4/21/2021 | Cubicin | Daptomycin | Cubist | Hisun Pharm Hangzhou |
| 4/21/2021 | Foscavir | Foscarnet Sodium | Pfizer | Gland Pharma |
| 4/21/2021 | Rythmol SR | Propafenone HCl | GlaxoSmithKline | Zydus |
| 4/21/2021 | Sinequan | Doxepin HCl | Pfizer | Alembic Pharms |
| 4/22/2021 | Adderall | Dextroamp Saccharate / Amp Aspartate / Dextroamp Sulfate / Amp Sulfate | Teva | Ascent Pharms |
| 4/22/2021 | Compazine | Prochlorperazine Edisylate | GlaxoSmithKline | Caplin |
| 4/23/2021 | Rheumatrex | Methotrexate Sodium | Endo | Lotus Pharm |
| 4/23/2021 | Bentyl | Dicyclomine HCl | Adare | Novitium Pharma |
| 4/26/2021 | Magnesium Sulfate | Magnesium Sulfate | Hospira | B Braun Medical |
| 4/26/2021 | Lescol XL | Fluvastatin Sodium | Novartis | Beijing |
| 4/26/2021 | Librax | Chlordiazepoxide HCl / Clidinium Bromide | Bausch & Lomb | Alkem Labs |
| 4/26/2021 | Thiola | Tiopronin | Mission Pharma | Teva |
| 4/27/2021 | Viibryd | Vilazodone HCl | AbbVie | Accord Healthcare |
| 4/28/2021 | Duac | Clindamycin Phosphate / Benzoyl Peroxide | Glaxo | Encube |
| 4/28/2021 | Northera | Droxidopa | Lundbeck | Bionpharma |
| 4/29/2021 | Lidoderm | Lidocaine | Teikoku Pharma | Nal Pharm |
| 4/29/2021 | Revatio | Sildenafil Citrate | Pfizer | Appco |
| 4/30/2021 | Reyataz | Atazanavir Sulfate | Bristol-Myers Squibb | Laurus Labs |
| 4/30/2021 | Robaxin | Methocarbamol | Auxilium | MLV |
| 4/30/2021 | Sanctura XR | Trospium Chloride | Allergan | AMTA |
| 5/3/2021 | Nitrostat | Nitroglycerin | Pfizer | Rubicon |
| 5/3/2021 | Butrans | Buprenorphine | Purdue | Mylan |
| 5/3/2021 | Zoloft | Sertraline HCl | Upjohn | Ascent Pharms |
| 5/4/2021 | Focalin XR | Dexmethylphenidate HCl | Novartis | Mylan |
| 5/4/2021 | Cosopt | Dorzolamide HCl / Timolol Maleate | Akorn | Alembic Pharms |
| 5/5/2021 | Northera | Droxidopa | Lundbeck | Tris Pharma |
| 5/6/2021 | Onfi | Clobazam | Lundbeck | Alkem Labs |
| 5/6/2021 | Levophed | Norepinephrine Bitartrate | Hospira | Gland Pharma |
| 5/7/2021 | Claritin | Loratadine | Bayer | Hetero Labs |
| 5/7/2021 | Kerydin | Tavaborole | Anacor | Taro Pharms |
| 5/7/2021 | Sinemet | Carbidopa / Levodopa | Merck Sharp and Dohme | Sciegen Pharms |
| 5/10/2021 | Arava | Leflunomide | Sanofi Aventis | Aet Pharma |
| 5/10/2021 | Tarceva | Erlotinib HCl | Roche | MSN |
| 5/10/2021 | Librax | Chlordiazepoxide HCl / Clidinium Bromide | Bausch & Lomb | Dr Reddy's |
| 5/10/2021 | Neurontin | Gabapentin | Upjohn | Ascent Pharms |
| 5/11/2021 | Banzel | Rufinamide | Eisai | Hetero Labs |
| 5/11/2021 | Revatio | Sildenafil Citrate | Upjohn | Hetero Labs |
| 5/11/2021 | Onfi | Clobazam | Lundbeck | MSN |
| 5/13/2021 | Latuda | Lurasidone HCl | Sunovion | Alembic Pharms |
| 5/13/2021 | Tygacil | Tigecycline | PF Prism | Hong Kong |
| 5/13/2021 | Sabril | Vigabatrin | Lundbeck | Dexcel Pharma |
| 5/14/2021 | Cosopt | Dorzolamide HCl / Timolol Maleate | Akorn | Aurobindo |
| 5/14/2021 | Xtandi | Enzalutamide | Astellas | Actavis |
| 5/14/2021 | Miacalcin | Calcitonin-Salmon | Mylan | Custopharm |
| 5/14/2021 | Jadenu | Deferasirox | Novartis | Annora Pharma |
| 5/17/2021 | Renvela | Sevelamer Carbonate | Genzyme | Bionpharma |
| 5/18/2021 | Nebcin | Tobramycin Sulfate | Eli Lilly | Gland Pharma |
| 5/18/2021 | Ranexa | Ranolazine | Gilead | Accord Healthcare |
| 5/19/2021 | Isuprel | Isoproterenol HCl | Bausch & Lomb | Amring Pharms |
| 5/19/2021 | Zovirax | Acyclovir | Bausch & Lomb | Macleods |
| 5/19/2021 | Amitid | Amitriptyline HCl | BMS | Unichem |
| 5/20/2021 | Zortress | Everolimus | Novartis | Breckenridge |
| 5/20/2021 | Ketozole | Ketoconazole | Taro | Encube |
| 5/21/2021 | Revlimid | Lenalidomide | Celgene | Natco Pharma |
| 5/21/2021 | Augmentin | Amoxicillin / Clavulanate Potassium | US Antibiotics | Micro Labs |
| 5/21/2021 | Zinc Chloride | Zinc Chloride | Hospira | Exela Pharma |
| 5/21/2021 | Firazyr | Icatibant Acetate | Shire | Glenmark |
| 5/21/2021 | Extina | Ketoconazole | Mylan | Xiromed |
| 5/27/2021 | Jadenu | Deferasirox | Novartis | Celltrion |
| 5/27/2021 | Imodium | Loperamide HCl / Simethicone | Johnson & Johnson | Guardian Drug |
| 5/27/2021 | Permitil | Fluphenazine HCl | Schering | Zydus |
| 5/28/2021 | Vicoprin | Hydrocodone Bitartrate / Aspirin | Abbott | LGM Pharma |
| 5/28/2021 | Alkeran | Melphalan HCl | Apotex | Hong Kong |
| 5/28/2021 | Angiomax | Bivalirudin | Sandoz | Hainan Poly Pharm |
| 6/1/2021 | Proventil HFA | Albuterol Sulfate | Kindeva | Sandoz |
| 6/1/2021 | Xeljanz | Tofacitinib Citrate | PF Prism | Ajanta Pharma |
| 6/2/2021 | Mycamine | Micafungin Sodium | Astellas | Xellia Pharms |
| 6/2/2021 | Oxycodone HCl | Oxycodone HCl | Genus | Quagen |
| 6/2/2021 | Thorazine | Chlorpromazine HCl | Glaxo | Genus |
| 6/3/2021 | Theophylline | Theophylline | Alembic | Glenmark |
| 6/4/2021 | Kaletra | Lopinavir / Ritonavir | AbbVie | Hetero Labs |
| 6/4/2021 | Truvada | Emtricitabine / Tenofovir Disoproxil Fumarate | Gilead | Lupin |
| 6/7/2021 | Zenzendi | Dextroamphetamine Sulfate | Arbor | Winder Labs |
| 6/10/2021 | Effexor XR | Venlafaxine HCl | Osmotica | Alkem Labs |
| 6/11/2021 | Kyprolis | Carfilzomib | Amgen | Breckenridge |
| 6/11/2021 | Faslodex | Fulvestrant | AstraZeneca | Apotex |
| 6/11/2021 | Mirapex ER | Pramipexole Dihydrochloride | Boehringer-Ingelheim | Xiamen LP Pharm |
| 6/11/2021 | Keppra | Levetiracetam | UCB | Sciegen Pharms |
| 6/14/2021 | Amicar | Aminocaproic Acid | Akorn | Edenbridge Pharms |
| 6/14/2021 | Axiron | Testosterone | Eli Lilly | Aleor Dermaceuticals |
| 6/14/2021 | Intelence | Etravirine | Johnson & Johnson | Amneal |
| 6/14/2021 | Akovaz | Ephedrine Sulfate | Exela | Aurobindo |
| 6/14/2021 | Clobex | Clobetasol Propionate | Galderma | Amneal |
| 6/15/2021 | Kuvan | Sapropterin Dihydrochloride | Biomarin | Dr Reddy's |
| 6/15/2021 | Suboxone | Buprenorphine HCl / Naloxone HCl | Indivior | Alkem |
| 6/16/2021 | Sustiva | Efavirenz | Bristol-Myers Squibb | Strides |
| 6/16/2021 | Boniva | Ibandronate Sodium | Roche | Nang Kuang |
| 6/16/2021 | Truvada | Emtricitabine / Tenofovir Disoproxil Fumarate | Gilead | Apotex |
| 6/16/2021 | Renagel | Sevelamer HCl | Genzyme | Lupin |
| 6/17/2021 | Imodium | Loperamide HCl / Simethicone | Johnson & Johnson | Hetero Labs |
| 6/17/2021 | Levo-Dromoran | Levorphanol Tartrate | Valeant | Sun Pharm |
| 6/21/2021 | Jublia | Efinaconazole | Bausch & Lomb | Acrux DDS |
| 6/21/2021 | Trileptal | Oxcarbazepine | Novartis | Glasshouse Pharms |
| 6/22/2021 | Perforomist | Formoterol Fumarate | Mylan | Teva |
| 6/22/2021 | Brovana | Arformoterol Tartrate | Sunovion | Cipla |
| 6/22/2021 | Brovana | Arformoterol Tartrate | Sunovion | Glenmark |
| 6/22/2021 | Brovana | Arformoterol Tartrate | Sunovion | Axar Pharms |
| 6/25/2021 | Gemzar | Gemcitabine HCl | Eli Lilly | Hikma |
| 6/25/2021 | Macrodantin | Nitrofurantoin | Almatica | Alembic |
| 6/25/2021 | Taxotere | Docetaxel | Sanofi Aventis | Eugia Pharma |
| 6/28/2021 | Cleocin T | Clindamycin Phosphate | Pfizer | Taro Pharms |
| 6/29/2021 | Aloxi | Palonosetron HCl | Eli Lilly | Emcure |
| 6/29/2021 | Aptiom | Eslicarbazepine Acetate | Sunovion | Dr Reddys |
| 6/29/2021 | Cubicin | Daptomycin | Cubist | Hong Kong |
| 6/29/2021 | Cubicin | Daptomycin | Sagent | Hong Kong |
| 6/30/2021 | Vascepa | Icosapent Ethyl | Amarin | Apotex |
| 6/30/2021 | Otezla | Apremilast | Amgen | Amneal |
| 6/30/2021 | Effexor XR | Venlafaxine HCl | Wyeth | Appco |
