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 |
|---|---|---|---|---|
| 10/1/2021 | Bloxiverz | Neostigmine Methylsulfate | Exela | Indoco |
| 10/1/2021 | Cancidas | Caspofungin Acetate | Merck | UBI |
| 10/1/2021 | Mexitil | Mexiletine HCl | Boehringer-Ingelheim | Havix |
| 10/1/2021 | Neurontin | Gabapentin | Upjohn | Ascent Pharms |
| 10/1/2021 | Tamiflu | Oseltamivir Phosphate | Roche | Epic |
| 10/4/2021 | Emend | Fosaprepitant Dimeglumine | Merck | Praxgen |
| 10/4/2021 | Rhofade Cream, 1% | Oxymetazoline HCl | EPI Health | Taro |
| 10/5/2021 | Diovan | Valsartan | Novartis | Dr Reddy's |
| 10/5/2021 | Sinemet CR | Carbidopa / Levodopa | Organon | ScieGen |
| 10/6/2021 | Imodium | Loperamide HCl | Johnson & Johnson | Edenbridge |
| 10/7/2021 | Truvada | Emtricitabine / Tenofovir Disoproxil Fumarate | Gilead | Hetero |
| 10/7/2021 | Efudex | Fluorouracil | Bausch | Accord |
| 10/7/2021 | Trisenox | Arsenic Trioxide | Teva | Gland Pharma |
| 10/8/2021 | Cuprimine | Penicillamine | Bausch | Navinta |
| 10/8/2021 | Cataflam | Diclofenac Potassium | Amici | Riconpharma |
| 10/12/2021 | Istodax | Romidepsin | Celgene | Fresenius Kabi |
| 10/12/2021 | Diprivan | Propofol | Fresenius Kabi | Emcure |
| 10/12/2021 | Doxil | Doxorubicin HCl | Baxter Healthcare | Ayana Pharma |
| 10/12/2021 | Mivacron | Mivacurium Chloride | AbbVie | Woodward |
| 10/13/2021 | Robinul | Glycopyrrolate | Hikma | Nivagen Pharms |
| 10/13/2021 | Carbaglu | Carglumic Acid | Recordati | ANI |
| 10/14/2021 | Welchol | Colesevelam HCl | Daiichi Sankyo | Beijing Tide Pharm |
| 10/14/2021 | Revlimid | Lenalidomide | Celgene | Dr. Reddy's |
| 10/14/2021 | Cogentin | Benztropine Mesylate | Akorn | Hikma |
| 10/14/2021 | Tikosyn | Dofetilide | Pfizer | Granules |
| 10/14/2021 | Metrogel-Vaginal | Metronidazole | Bausch | Solaris |
| 10/14/2021 | Decadron | Dexamethasone | Merck | Amneal |
| 10/15/2021 | Trisenox | Arsenic Trioxide | Teva | Eugia Pharma |
| 10/15/2021 | Pepcid | Famotidine | Bausch | Ascent Pharms |
| 10/18/2021 | Zortress | Everolimus | Novartis | Par |
| 10/19/2021 | Questran Light | Cholestyramine Light | Bristol-Myers Squibb | Alkem Labs |
| 10/19/2021 | Questran | Cholestyramine | Bristol-Myers Squibb | Alkem Labs |
| 10/19/2021 | Zipsor | Diclofenac Potassium | Assertio | Aurobindo |
| 10/19/2021 | Quelicin | Succinylcholine Chloride | Hospira | Hong Kong |
| 10/20/2021 | Soma | Carisoprodol | Mylan | MLV |
| 10/20/2021 | Potassium Acetate | Potassium Acetate | Hospira | Exela Pharma |
| 10/20/2021 | Permitil | Fluphenazine HCl | Schering | Enaltec |
| 10/20/2021 | Mutamycin | Mitomycin | Bristol | Gland Pharma |
| 10/21/2021 | Monurol | Fosfomycin Tromethamine | Zambon | Alkem |
| 10/22/2021 | Imodium | Loperamide HCl | Johnson & Johnson | Bionpharma |
| 10/25/2021 | Inspra | Eplerenone | Upjohn | Westminster Pharms |
| 10/25/2021 | Mepron | Atovaquone | Glaxo | Abon |
| 10/25/2021 | Librax | Chlordiazepoxide HCl / Clidinium Bromide | Bausch | Amneal |
| 10/25/2021 | Tenoretic | Atenolol / Chlorthalidone | Almatica | ANI |
| 10/25/2021 | Thorazine | Chlorpromazine HCl | Glaxo | Teva |
| 10/27/2021 | Diovan | Valsartan | Novartis | ScieGen |
| 10/29/2021 | Duexis | Ibuprofen / Famotidine | Horizon | Teva |
| 10/29/2021 | Zebeta | Bisoprolol Fumarate | Teva | Novitium Pharma |
| 11/2/2021 | Librax | Chlordiazepoxide HCl / Clidinium Bromide | Horizon | Teva |
| 11/2/2021 | Fusilev | Levoleucovorin Calcium | Spectrum | Praxgen |
| 11/2/2021 | CellCept | Mycophenolate Mofetil | Roche | Amneal |
| 11/3/2021 | Lymphazurin | Isosulfan Blue | Mylan | Hong Kong |
| 11/3/2021 | Zymaxid | Gatifloxacin | AbbVie | Torrent |
| 11/3/2021 | Myfortic | Mycophenolic Sodium | Novartis | Twi |
| 11/3/2021 | Pepcid AC | Famotidine | Johnson & Johnson | Ascent Pharms |
| 11/4/2021 | Westcort | Hydrocortisone Valerate | Sun | Encube |
| 11/4/2021 | Lyrica CR | Pregabalin | Pfizer | Mylan |
| 11/4/2021 | Cialis | Tadalafil | Lilly | VKT Pharma |
| 11/4/2021 | Ziac | Bisoprolol Fumarate / Hydrochlorothiazide | Teva | Novitium Pharma |
| 11/4/2021 | Pepcid AC | Famotidine | Johnson & Johnson | Annora Pharma |
| 11/5/2021 | Focalin XR | Dexmethylphenidate HCl | Novartis | Sun |
| 11/8/2021 | Azactam | Aztreonam | Bristol-Myers Squibb | Pfizer |
| 11/8/2021 | Magnesium Sulfate | Magnesium Sulfate | Hospira | PTS Consulting |
| 11/8/2021 | Xylocaine | Lidocaine HCl | Fresenius Kabi | Aspiro |
| 11/8/2021 | Pepcid AC | Famotidine | Johnson & Johnson | Annora Pharma |
| 11/9/2021 | Brovana | Arformoterol Tartrate | Sunovion | Teva |
| 11/9/2021 | Potassium Chloride / Dextrose | Potassium Chloride / Dextrose | ICU Medical | Fresenius Kabi |
| 11/9/2021 | Androgel | Testosterone | AbbVie | Encube |
| 11/9/2021 | Robinul | Glycopyrrolate | Robins AH | Zydus |
| 11/10/2021 | Gilenya | Fingolimod HCl | Novartis | HEC |
| 11/10/2021 | Baraclude | Entecavir | Bristol-Myers Squibb | Yung Shin Pharm |
| 11/10/2021 | Miacalcin | Calcitonin-Salmon | Mylan | Par |
| 11/10/2021 | Carnitor | Levocarnitine | Leadiant | Saptalis |
| 11/12/2021 | Aloxi | Palonosetron HCl | Roche | Baxter |
| 11/12/2021 | Gilenya | Fingolimod HCl | Novartis | Teva |
| 11/15/2021 | Zovirax | Acyclovir | Bausch | Prinston Inc |
| 11/15/2021 | Lovaza | Omega-3-Acid Ethyl Esters | Glaxo | Mankind |
| 11/16/2021 | Bactroban | Mupirocin | Glaxo | Alembic/Aleor |
| 11/16/2021 | Gabitril | Tiagabine HCl | Teva | MSN |
| 11/16/2021 | Revatio | Sildenafil Citrate | Pfizer | Taro |
| 11/16/2021 | Deltasone | Prednisone | Pharmacia / Upjohn | Aurobindo |
| 11/17/2021 | Durezol | Difluprednate | Novartis | Amneal |
| 11/17/2021 | Revatio | Sildenafil Citrate | Pfizer | Tris |
| 11/17/2021 | Arranon | Nelarabine | Novartis | Zydus |
| 11/17/2021 | Nizoral | Ketoconazole | Janssen | Tasman Pharma |
| 11/18/2021 | Azilect | Rasagiline Mesylate | Teva | Dr. Reddy's |
| 11/19/2021 | Isuprel | Isoproterenol HCl | Bausch | Avet Lifesciences |
| 11/19/2021 | Jadenu Sprinkle | Deferasirox | Novartis | Teva |
| 11/19/2021 | Dacogen | Decitabine | Otsuka | Zydus |
| 11/22/2021 | Vibramycin | Doxycycline Hyclate | Pfizer | Nesher Pharms |
| 11/22/2021 | Adderall | Amphetamine / Dextroamphetamine | Teva | Accord Healthcare |
| 11/22/2021 | Niaspan | Niacin | AbbVie | Beijing |
| 11/22/2021 | Perforomist | Formoterol Fumarate | Mylan | Alembic |
| 11/22/2021 | Digoxin | Digoxin | Concordia | ANI / Novitium |
| 11/23/2021 | Focalin XR | Dexmethylphenidate HCl | Novartis | IntelliPharmaceutics |
| 11/23/2021 | Sprycel | Dasatinib | Bristol-Myers Squibb | Apotex |
| 11/23/2021 | Afinitor | Everolimus | Novartis | Hikma |
| 11/23/2021 | Isordil | Isosorbide Dinitrate | Bausch | Par |
| 11/23/2021 | Temodar | Temozolomide | Merck Sharp Dohme | Nivagen Pharms |
| 11/23/2021 | Cystadone | Betaine | Orphan Europe | ANI |
| 11/26/2021 | Zortress | Everolimus | Novartis | Alkem Labs Ltd |
| 11/26/2021 | Adderall XR | Amphetamine / Dextroamphetamine | Takeda | Lannett Co Inc |
| 11/26/2021 | Cubicin | Daptomycin | Cubist Pharms | Hangzhou Zhongmei |
| 11/26/2021 | Atropine Sulfate | Atropine Sulfate | Akorn | Apotex |
| 11/29/2021 | Myfortic | Mycophenolic Acid | Novartis | Bionpharma |
| 11/30/2021 | Amitiza | Lubiprostone | Takeda | Amneal |
| 11/30/2021 | Sutent | Sunitinib Malate | Pfizer | Teva |
| 12/1/2021 | Abilify | Aripiprazole | Bristol-Myers Squibb | Unichem |
| 12/1/2021 | Atropine Sulfate | Atropine Sulfate | Fresenius Kabi | Hikma |
| 12/2/2021 | Sensipar | Cinacalcet HCl | Amgen | Amneal |
| 12/2/2021 | Ravicti | Glycerol Phenylbutyrate | Horizon | Par |
| 12/2/2021 | Trisenox | Arsenic Trioxide | Teva | Sandoz |
| 12/3/2021 | Glucophage | Metformin HCl | EMD Serono | Harman Finochem |
| 12/6/2021 | Sutent | Sunitinib Malate | Pfizer | Mylan |
| 12/7/2021 | Uloric | Febuxostat | Takeda | Alkem |
| 12/8/2021 | Thioplex | Thiotepa | Amgen | Beloteca |
| 12/8/2021 | Lamictal XR | Lamotrigine | Glaxo | Yiling |
| 12/8/2021 | Focalin XR | Dexmethylphenidate HCl | Novartis | Hetero |
| 12/9/2021 | NuvaRing | Ethinyl Estradiol / Etonogestrel | Merck | Dr. Reddy's |
| 12/13/2021 | Timoptic in Ocudose | Timolol Maleate | Bausch | IndentiRx |
| 12/13/2021 | Glumetza | Metformin HCl | Bausch | Apotex |
| 12/13/2021 | Advair Diskus | Fluticasone Propionate / Salmeterol Xinafoate | Glaxo | Teva |
| 12/14/2021 | AmBiosone | Amphotericin B | Astellas | Sun |
| 12/15/2021 | Vasostrict | Vasopressin | Endo / Par | Eagle |
| 12/17/2021 | Bystolic | Nebivolol HCl | AbbVie | Cadila Pharms |
| 12/17/2021 | Bystolic | Nebivolol HCl | AbbVie | Aurobindo |
| 12/17/2021 | Bystolic | Nebivolol HCl | AbbVie | Reyoung |
| 12/17/2021 | Mycobutin | Rifabutin | Pfizer | ANI |
| 12/21/2021 | Periactin | Cyproheptadine HCl | Merck | Tris Pharma |
| 12/21/2021 | Tecfidera | Dimethyl Fumarate | Biogen | Sawai |
| 12/22/2021 | Depacon | Valproate Sodium | AbbVie | Mylan |
| 12/22/2021 | Atripla | Efavirenz / Emtricitabine / Tenofovir Disoproxil Fumarate | Gilead | Laurus |
| 12/23/2021 | Renagel | Sevelamer Carbonate | Genzyme | Lupin |
| 12/23/2021 | Minipress | Prazosin HCl | Pfizer | Granules |
| 12/27/2021 | Cerdelga | Eliglustat Tartrate | Genzyme | Teva |
| 12/27/2021 | Rapamune | Sirolimus | Pfizer | Torrent |
| 12/28/2021 | AccuNeb | Albuterol Sulfate | Mylan | RiteDose |
| 12/28/2021 | Adderall | Amphetamine / Dextroamphetamine | Teva | Granules |
| 12/30/2021 | Corlanor | Ivabradine HCl | Amgen | Centaur Pharms |
