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 | ANDA Holder | ANDA Applicant |
|---|---|---|---|---|
| 1/3/2023 | Depo-Medrol | Methylprednisolone Acetate | Pfizer | Slayback |
| 1/4/2023 | Toviaz | Fesoterodine Fumarate | Pfizer | Ani Pharms |
| 1/4/2023 | Toviaz | Fesoterodine Fumarate | Pfizer | Actavis |
| 1/4/2023 | Toviaz | Fesoterodine Fumarate | Pfizer | Alembic |
| 1/4/2023 | Toviaz | Fesoterodine Fumarate | Pfizer | Amneal |
| 1/4/2023 | Toviaz | Fesoterodine Fumarate | Pfizer | Accord Healthcare |
| 1/5/2023 | Toviaz | Fesoterodine Fumarate | Pfizer | Lupin |
| 1/5/2023 | Vimpat | Lacosamide | UCB | Actavis |
| 1/5/2023 | Vimpat | Lacosamide | UCB | Aurobindo |
| 1/5/2023 | Depo-Provera | Medroxyprogesterone Acetate | Pfizer | Hikma |
| 1/5/2023 | Retin-A | Tretinoin | Bausch | Taro Pharms |
| 1/5/2023 | Permitil | Fluphenazine HCl | Schering | Ajanta Pharma |
| 1/5/2023 | Jevtana Kit | Cabazitaxel | Sanofi | Sandoz |
| 1/6/2023 | Fetzima | Levomilnacipran HCl | AbbVie | Aurobindo |
| 1/6/2023 | Briviact | Brivaracetam | UCB | Aurobindo |
| 1/6/2023 | Nor-QD | Emzahh | Teva | Aurobindo |
| 1/9/2023 | Uloric | Febuxostat | Takeda | Zydus |
| 1/9/2023 | Effient | Prasugrel | Eli Lilly | Lupin |
| 1/9/2023 | Orfadin | Nitisinone | Swedish Orphan | Torrent |
| 1/9/2023 | Wellbutrin SR | Bupropion HCl | GlaxoSmithKline | Yichang Humanwell |
| 1/10/2023 | Glumetza | Metformin HCl | Bausch | Micro Labs |
| 1/10/2023 | Rexulti | Brexpiprazole | Otsuka | Zydus |
| 1/10/2023 | Naproxen | Naproxen Sodium | Bionpharma | Patheon Softgels |
| 1/10/2023 | Arranon | Nelarabine | Novartis | Kindos |
| 1/11/2023 | Phenylephrine HCl | Phenylephrine HCl | Akorn | Mankind |
| 1/12/2023 | Restasis | Cyclosporine | AbbVie | Apotex |
| 1/12/2023 | Infumorph | Morphine Sulfate | Hikma | Hikma |
| 1/12/2023 | Hetlioz | Tasimelteon | Vanda | MSN |
| 1/13/2023 | Ketalar | Ketamine HCl | Par | Fresenius Kabi |
| 1/13/2023 | Rykindo | Risperidone | Luye Pharma | Luye Pharma |
| 1/17/2023 | Celestone Soluspan | Betamethasone Acetate / Betamethasone Sodium Phosphate | Organon | Hikma |
| 1/18/2023 | Welchol | Colesevelam HCl | Cosette | Impax |
| 1/18/2023 | Unithroid | Levothyroxine Sodium | Amneal | Ascent Pharms |
| 1/18/2023 | Neurontin | Gabapentin | Pfizer | Rubicon |
| 1/18/2023 | Remeron | Mirtazapine | Organon | Prasco |
| 1/18/2023 | Benicar | Olmesartan Medoxomil | Cosette | MSN |
| 1/19/2023 | Imitrex | Sumatriptan Succinate | Glaxo | Baxter Healthcare |
| 1/19/2023 | Nasacort | Triamcinolone Acetonide | Sanofi | Apotex |
| 1/19/2023 | Rapamune | Sirolimus | Pfizer | MSN |
| 1/20/2023 | Nebupent | Pentamidine Isethionate | Fresenius Kabi | X-Gen Pharms Inc |
| 1/23/2023 | Primacor | Milrinone Lactate | Sanofi | Shandong |
| 1/23/2023 | Metrogel | Metronidazole | Galderma Labs | Cosette |
| 1/23/2023 | Adderall XR | Dextroamp Saccharate / Amp Aspartate / Dextroamp Sulfate / Amp Sulfate | Takeda | Granules |
| 1/24/2023 | Duragesic-100 | Fentanyl-100 | Janssen | Zydus Noveltech Inc |
| 1/24/2023 | Duragesic-12 | Fentanyl-12 | Janssen | Zydus Noveltech Inc |
| 1/24/2023 | Duragesic-25 | Fentanyl-25 | Janssen | Zydus Noveltech Inc |
| 1/24/2023 | Duragesic-37 | Fentanyl-37 | Janssen | Zydus Noveltech Inc |
| 1/24/2023 | Duragesic-50 | Fentanyl-50 | Janssen | Zydus Noveltech Inc |
| 1/24/2023 | Duragesic-75 | Fentanyl-75 | Janssen | Zydus Noveltech Inc |
| 1/24/2023 | Paraflex | Chlorzoxazone | Ortho McNeil | Belcher |
| 1/24/2023 | Ketalar | Ketamine HCl | Par | Gland Pharma Ltd |
| 1/24/2023 | Entereg | Alvimopan | Merck | Par Pharm |
| 1/25/2023 | Chantix | Varenicline Tartrate | PF Prism | Apotex |
| 1/26/2023 | Zytiga | Abiraterone Acetate | Janssen | Teva |
| 1/26/2023 | Cysteine HCl | Cysteine HCl | Hospira | Nivagen Pharms |
| 1/26/2023 | Imodium | Loperamide HCl | Johnson & Johnson | Rubicon |
| 1/27/2023 | Paraflex | Chlorzoxazone | Ortho McNeil | Appco |
| 1/27/2023 | Capoten | Captopril | Strides | Changzhou Pharm |
| 1/27/2023 | Triamcinolone Acetonide | Triamcinolone Acetonide | Padagis | Glasshouse Pharms |
| 1/30/2023 | Theophylline | Theophylline | Akorn | Leading |
| 1/30/2023 | Cubicin | Daptomycin | Merck | Xellia |
| 1/31/2023 | Levetiracetam In Sodium Chloride | Levetiracetam In Sodium Chloride | HQ Specialty Pharma | Fresenius Kabi USA |
| 1/31/2023 | Bacteriostatic Water for Injection | Sterile Water For Injection | Hospira | Hikma |
| 1/31/2023 | Rexulti | Brexpiprazole | Otsuka | Amneal |
| 2/1/2023 | Nebcin | Tobramycin Sulfate | Eli Lilly | Hainan Poly |
| 2/2/2023 | Vfend | Voriconazole | PF Prism | Eugia Pharma |
| 2/2/2023 | Quelicin | Succinylcholine Chloride | Hospira | Mankind |
| 2/3/2023 | Pennsaid 2% | Diclofenac Sodium | Horizon | Aurolife Pharma |
| 2/3/2023 | Rexulti | Brexpiprazole | Otsuka | Ajanta Pharma |
| 2/6/2023 | Vinpat | Lacosamide | UCB | Medley Pharms |
| 2/7/2023 | Linzess | Linaclotide | AbbVie | Aurobindo |
| 2/7/2023 | Robinul | Glycopyrrolate | Hikma | Lupin |
| 2/7/2023 | Aggrastat | Tirofiban HCl | Medicure | Nexus Pharms |
| 2/8/2023 | Revlimid | Lenalidomide | Celgene | Sun Pharm |
| 2/8/2023 | Fentanyl Citrate | Fentanyl Citrate | Exela | Exela |
| 2/9/2023 | Rozerem | Ramelteon | Takeda | Micro Labs |
| 2/9/2023 | Vimpat | Lacosamide | UCB | MSN |
| 2/9/2023 | Trokendi XR | Topiramate | Supernus | Zydus |
| 2/9/2023 | Protonix | Pantoprazole Sodium | Wyeth | Ajanta Pharma |
| 2/10/2023 | Jevtana Kit | Cabazitaxel | Sanofi | Dr Reddys |
| 2/10/2023 | Jevtana Kit | Cabazitaxel | Sanofi | Apotex |
| 2/13/2023 | Iressa | Gefitinib | AstraZeneca | Qilu Pharm Hainan |
| 2/13/2023 | Alesse | Levonorgestrel / Ethinyl Estradiol | Cadence | Hetero Labs |
| 2/13/2023 | Apresoline | Hydralazine HCl | Novartis | Eugia Pharma |
| 2/13/2023 | Hemabate | Carboprost Tromethamine | Pfizer | Caplin |
| 2/14/2023 | Treanada | Bendamustine HCl | Teva | Breckenridge |
| 2/14/2023 | Tamiflu | Oseltamivir Phosphate | Roche | Epic Pharma |
| 2/15/2023 | Rapamune | Sirolimus | Johnson & Johnson | Zydus |
| 2/15/2023 | Magnesium Sulfate In Plastic Container | Magnesium Sulfate In Plastic Container | Hospira | Amneal |
| 2/17/2023 | Revlimid | Lenalidomide | Celgene | Torrent |
| 2/17/2023 | Sinequan | Doxepin HCl | Pfizer | Teva |
| 2/17/2023 | Bloxiverz | Neostigmine Methylsulfate | Exela | Sagent Pharms |
| 2/21/2023 | Rythmol SR | Propafenone HCl | GlaxoSmithKline | Aurobindo |
| 2/22/2023 | Livalo | Pitavastatin Calcium | Kowa | Zydus |
| 2/22/2023 | Lioresal | Baclofen | Amneal | Rubicon |
| 2/23/2023 | Cozaar | Losartan Potassium | Organon | Granules |
| 2/23/2023 | Prevduo | Neostigmine Methylsulfate / Glycopyrrolate | Slayback | Slayback |
| 2/24/2023 | Benicar HCT | Olmesartan Medoxomil / Hydrochlorothiazide | Cosette | Zydus |
| 2/24/2023 | Zyprexa | Olanzapine | Eli Lilly | Cadila Pharms |
| 2/24/2023 | Thiola EC | Tiopronin | Mission | Par |
| 2/27/2023 | Eliquis | Apixaban | Bristol-Myers Squibb | Zydus |
| 2/27/2023 | Isovue-M 200 | Iopamidol | Bracco | Hainan Poly |
| 2/27/2023 | Mexitil | Mexiletine HCl | Boehringer-Ingelheim | Leading |
| 2/27/2023 | Robinul | Glycopyrrolate | Hikma | Mankind |
| 2/28/2023 | Zovirax | Acyclovir | Bausch | Zydus |
| 2/28/2023 | Phenylephrine HCl | Phenylephrine HCl | Hikma | Avet Lifesciences |
| 2/28/2023 | Advil Dual Action | Acetaminophen / Ibuprofen | GlaxoSmithKline | Perrigo |
| 2/28/2023 | Ganirelix | Ganirelix Acetate | Merck | Gland Pharma |
| 2/28/2023 | Taxotere | Docetaxel | Sanofi | Alembic |
| 3/1/2023 | Trokendi XR | Topiramate | Supernus | Par |
| 3/1/2023 | Cardizem SR | Diltiazem HCl | Bausch | Twi |
| 3/1/2023 | Combogesic | Acetaminophen / Ibuprofen | AFT Pharma | AFT Pharma |
| 3/2/2023 | Avelox | Moxifloxacin HCl | Bayer | Hetero Labs |
| 3/2/2023 | Viread | Tenofovir Disoproxil Fumarate | Gilead | Reyoung Pharm |
| 3/2/2023 | Sabril | Vigabatrin | Lundbeck | Zydus |
| 3/2/2023 | Zemuron | Rocuronium Bromide | Organon | Caplin |
| 3/2/2023 | Tegretol XR | Carbamazepine | Novartis | Sciecure Pharma |
| 3/2/2023 | Renvela | Sevelamer Carbonate | Sanofi | Hangzhou Anprime |
| 3/3/2023 | Arranon | Nelarabine | Novartis | Shorla |
| 3/3/2023 | Bicnu | Carmustine | Avet Lifesciences | Myla |
| 3/3/2023 | Cialis | Tadalafil | Eli Lilly | Novitium Pharma |
| 3/3/2023 | Fluorouracil | Fluorouracil | Spectrum | Alembic |
| 3/6/2023 | Revlimid | Lenalidomide | Celgene | Arrow |
| 3/6/2023 | Pylera | Bismuth Subcitrate Potassium / Metronidazole / Tetracycline HCl | AbbVie | Par |
| 3/6/2023 | Revlimid | Lenalidomide | Celgene | Zydus |
| 3/6/2023 | Revlimid | Lenalidomide | Celgene | Cipla |
| 3/6/2023 | Revlimid | Lenalidomide | Celgene | Lotus Pharm |
| 3/6/2023 | Revlimid | Lenalidomide | Celgene | Sun Pharm |
| 3/6/2023 | Revlimid | Lenalidomide | Celgene | Eugia Pharma |
| 3/6/2023 | Revlimid | Lenalidomide | Celgene | Mylan |
| 3/6/2023 | Revlimid | Lenalidomide | Celgene | Cipla |
| 3/6/2023 | Thiamine | Thiamine HCl | Fresenius Kabi | Caplin |
| 3/6/2023 | Minipress | Prazosin HCl | Pfizer | Alembic |
| 3/7/2023 | Revlimid | Lenalidomide | Celgene | Apotex |
| 3/7/2023 | Eryc | Erythromycin | Mayne | Zydus |
| 3/7/2023 | Gemzar | Gemcitabine HCl | Hospira | Hikma |
| 3/7/2023 | Potassium Chloride | Potassium Chloride | Genus | Belcher |
| 3/7/2023 | Cardizem LA | Diltiazem HCl | Bausch | Amta |
| 3/7/2023 | Narcan | Naloxone | Amphastar | Emergent |
| 3/8/2023 | Vascepa | Icosapent Ethyl | Amarin | Dr Reddys |
| 3/8/2023 | Zyrtec-D 12 Hour | Cetirizine HCl / Pseudoephedrine HCl | Johnson & Johnson | Aurobindo |
| 3/8/2023 | Naropin | Ropivacaine HCl | Fresenius Kabi USA | Amneal |
| 3/8/2023 | Pepcid AC | Famotidine | Johnson & Johnson | Marksans Pharma |
| 3/9/2023 | Zyprexa | Olanzapine | Eli Lilly | Zydus |
| 3/9/2023 | VFend | Voriconazole | PF Prism | UBI |
| 3/9/2023 | Truvada | Emtricitabine / Tenofovir Disoproxil Fumarate | Gilead | Aurobindo |
| 3/9/2023 | Emerphed | Ephedrine Sulfate | Nexus | Sagent |
| 3/9/2023 | Zovirax | Acyclovir | Mylan | MSN |
| 3/10/2023 | Alimta | Pemetrexed Disodium | Eli Lilly | Mylan |
| 3/10/2023 | Trokendi XR | Topiramate | Supernus | Actavis |
| 3/10/2023 | Latuda | Lurasidone HCl | Sunovion | Aurobindo |
| 3/10/2023 | Advil Cold and Sinus | Ibuprofen / Pseudoephedrine HCl | GlaxoSmithKline | Aurobindo |
| 3/10/2023 | Colestid | Colestipol HCl | Pfizer | Praxgen |
| 3/10/2023 | Cleocin | Clindamycin HCl | Pfizer | Glenmark |
| 3/13/2023 | Aubagio | Teriflunomide | Sanofi | Hetero Labs |
| 3/13/2023 | Aubagio | Teriflunomide | Sanofi | Biocon Pharma |
| 3/13/2023 | Xeljanz | Tofacitinib Citrate | Pfizer | Micro Labs |
| 3/13/2023 | PhosLo GelCaps | Calcium Acetate | Fresenius | Square |
| 3/14/2023 | Xeljanz | Tofacitinib Citrate | Pfizer | Zydus |
| 3/15/2023 | Emtriva | Emtricitabine | Gilead | Aurobindo |
| 3/15/2023 | Lovenox | Enoxaparin Sodium | Sanofi | Shenzhen Techdow |
| 3/15/2023 | Cataflam | Diclofenac Potassium | Amici | Senores Pharms |
| 3/15/2023 | Nexium 24Hr | Esomeprazole Magnesium | AstraZeneca | Guardian Drug |
| 3/15/2023 | Duexis | Ibuprofen / Famotidine | Horizon | Ascent Pharms |
| 3/15/2023 | Gadavist | Gadobutrol | Bayer | Hainan Poly |
| 3/16/2023 | Ranexa | Ranolazine | Gilead | Unichem |
| 3/17/2023 | Prednisolone | Prednisolone | Watson | Aurobindo |
| 3/17/2023 | Compazine | Prochlorperazine Maleate | Glaxo | Glenmark |
| 3/18/2023 | Rexulti | Brexpiprazole | Otsuka | Lupin |
| 3/20/2023 | Fetzima | Levomilnacipran HCl | AbbVie | Prinston |
| 3/20/2023 | Tazorac | Tazarotene | AbbVie | Solaris Pharma |
| 3/20/2023 | Theo-Dur | Theophylline | Schering | Amneal |
| 3/20/2023 | Anafranil | Clomipramine HCl | SpecGX | Aurobindo |
| 3/20/2023 | DDAVP | Desmopressin Acetate | Ferring | Gland |
| 3/21/2023 | Sinequan | Doxepin HCl | Pfizer | Zydus |
| 3/21/2023 | Enstillar | Calcipotriene / Betamethasone Dipropionate | Leo | Glenmark |
| 3/21/2023 | Macrodantin | Nitrofurantoin | Almatica | Mankind |
| 3/22/2023 | Prandin | Repaglinide | Gemini Labs | Macleods |
| 3/22/2023 | Perforomist | Formoterol Fumarate | Mylan | Mankind |
| 3/22/2023 | Zyprexa | Olanzapine | Lilly | Aspiro |
| 3/23/2023 | Sinequan | Doxepin HCl | Pfizer | Zydus |
| 3/23/2023 | Timoptic-XE | Timolol Maleate | Bausch | Eugia |
| 3/23/2023 | Amitiza | Lubiprostone | Sucampo | Zydus |
| 3/23/2023 | Zytiga | Abiraterone Acetate | Johnson & Johnson | Florida |
| 3/23/2023 | Loperamide HCl | Loperamide HCl | Bionpharma | Zydus |
| 3/24/2023 | Claritin | Loratadine | Bayer | Aurobindo |
| 3/24/2023 | Amicar | Aminocaproic Acid | Akorn | Taro |
| 3/24/2023 | Tegretol XR | Carbamazepine | Novartis | Ajanta |
| 3/24/2023 | Bentyl | Dicyclomine HCl | Allergan | Corepharma |
| 3/24/2023 | Levothyroxine | Levothyroxine Sodium | Fresenius Kabi | Zydus |
| 3/28/2023 | Prevacid ODT | Lansoprazole | Takeda | Aurobindo |
| 3/28/2023 | Nexium | Esomeprazole Magnesium | AstraZeneca | Prinston |
| 3/28/2023 | Xylocaine Viscous | Lidocaine HCl | Fresenius Kabi | Rubicon |
| 3/28/2023 | Neurontin | Gabapentin | Viatris | Granules |
| 3/29/2023 | Climara | Estradiol | Bayer | Zydus |
| 3/29/2023 | Lyrica | Pregabalin | Upjohn | Aurobindo |
| 3/29/2023 | Alphagan P | Brimonidine Tartrate | AbbVie | Alembic |
| 3/29/2023 | Cardizem | Diltiazem HCl | Biovail Labs | Eugia Pharma |
| 3/30/2023 | Tradjenta | Linagliptin | Boehringer-Ingelheim | Zydus |
| 3/30/2023 | Jentadueto | Linagliptin / Metformin HCl | Boehringer-Ingelheim | Zydus |
| 3/30/2023 | Macrobid | Nitrofurantoin (Monohydrate / Macrocrystals) | Almatica | Aurobindo |
| 3/30/2023 | Vemlidy | Tenofovir Alafenamide | Gilead | Lupin |
| 3/30/2023 | Prolixin Decanoate | Fluphenazine Decanoate | Bristol-Myers Squibb | Gland Pharma |
| 3/30/2023 | Bystolic | Nebivolol HCl | AbbVie | Beximco Pharms |
| 3/31/2023 | Minipress | Prazosin HCl | Pfizer | Aurobindo |
| 3/31/2023 | Apriso | Mesalamine | Bausch | Aurobindo |
