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ANDA Approvals
New Drug Applications and 505(b)(2) Applications
Second Quarter
This ANDA Approvals 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 |
---|---|---|---|---|
04/03/2023 | Silenor | Doxepin HCl | Currax | MSN |
04/04/2023 | Effexor XR | Venlafaxine HCl | Upjohn | Nostrum |
04/04/2023 | Diamox | Acetazolamide | Teva | Zydus |
04/04/2023 | Lexiscan | Regadenoson | Astellas | Mylan |
04/04/2023 | Sinemet | Carbidopa / Levodopa | Organon | Zydus |
04/04/2023 | Arranon | Nelarabine | Novartis | Amneal |
04/04/2023 | Compazine | Prochlorperazine Maleate | GlaxoSmithKline | Bionpharma |
04/04/2023 | Daliresp | Roflumilast | AstraZeneca | Camber / Hetero |
04/05/2023 | Bepreve | Bepotastine Besilate | Bausch and Lomb | Alembic |
04/05/2023 | Clindamycin Phosphate in Dextrose 5% | Clindamycin Phosphate in Dextrose 5% | Abraxix | Hikma |
04/05/2023 | Bepreve | Bepotastine Besilate | Bausch and Lomb | Alembic |
04/06/2023 | Cardizem LA | Diltiazem HCl | Bausch | Sciegen Pharms |
04/06/2023 | Evoxac | Cevimeline HCl | Cosette | Rubicon |
04/07/2023 | Otezla | Apremilast | Amgen | Shilpa |
04/07/2023 | Zithromax | Azithromycin | Pfizer | Zydus |
04/10/2023 | Kerydin | Tavaborole | Anacor | Zydus |
04/10/2023 | Celebrex | Celecoxib | Upjohn | Yabao Pharm |
04/10/2023 | Paraflex | Chlorzoxazone | Ortho McNeil | Corepharma |
04/10/2023 | Sular | Nisoldipine | Covis | Amta |
04/11/2023 | Valcyte | Valganciclovir HCl | Cheplapharm | APPCO |
04/11/2023 | Zithromax | Azithromycin | Pfizer | Zydus |
04/11/2023 | Valcyte | Valganciclovir HCl | Cheplapharm | Appco |
04/12/2023 | Venlafaxine HCl | Venlafaxine HCl | Osmotica | Ajanta Pharma |
04/12/2023 | Uceris | Budesonide | Bausch | Padagis |
04/12/2023 | Doryx | Doxycycline Hyclate | Fresenius Kabi | Gland Pharma |
04/12/2023 | Alrex | Loteprednol Etabonate | Bausch and Lomb | Akorn |
04/12/2023 | Nexavar | Sorafenib Tosylate | Bayer | Torrent |
04/13/2023 | Depo-Medrol | Methylprednisolone Acetate | Pfizer | Eugia Pharma |
04/13/2023 | Depo-Testosterone | Testosterone Cypionate | Pfizer | Xiromed |
04/14/2023 | Isuprel | Isoproterenol HCl | Bausch | Zydus |
04/14/2023 | Furadantin | Nitrofurantoin | Casper Pharma | Novitium Pharma |
04/14/2023 | Piperacillin / Tazobactam | Piperacillin / Tazobactam | Wockhardt Bio | Shandong |
04/14/2023 | RizaFilm | Rizatriptan Benzoate | IntelGenx | IntelGenx |
04/17/2023 | Menostar | Estradiol | Bayer Healthcare | Zydus |
04/17/2023 | Prograf | Tacrolimus | Astellas | Hangzhou Zhongmei |
04/17/2023 | Daliresp | Roflumilast | AstraZeneca | Aurobindo |
04/17/2023 | Midazolam | Midazolam | InfoRLife | Hikma |
04/17/2023 | Compazine | Prochlorperazine Maleate | GlaxoSmithKline | Amneal |
04/18/2023 | Acetaminophen | Acetaminophen | B Braun Medical | Wockhardt Bio |
04/18/2023 | Daliresp | Roflumilast | AstraZeneca | Zydus |
04/18/2023 | Luxiq | Betamethasone Valerate | Mylan | Xiromed |
04/18/2023 | Daliresp | Roflumilast | AstraZeneca | Alkem |
04/18/2023 | Evoxac | Cevimeline HCl | Cosette | Aurobindo |
04/19/2023 | Viagra | Sildenafil Citrate | Vaitris | Macleods |
04/19/2023 | Nimbex | Cisatracurium Besylate | AbbVie | Hikma |
04/19/2023 | Renvela | Sevelamer Carbonate | Sanofi | Macleods |
04/19/2023 | Lopressor | Metoprolol Tartrate | Validus | Zydus |
04/19/2023 | Dexamethasone | Dexamethasone | Hikma | Bionpharma |
04/19/2023 | Acetadote | Acetylcysteine | Cumberland Pharms | Steriscience |
04/20/2023 | Trisenox | Arsenic Trioxide | Cephalon | Orbicular |
04/20/2023 | Vascepa | Icosapent Ethyl | Amarin Pharms | Zydus |
04/21/2023 | Brilinta | Ticagrelor | AstraZeneca | Alkem |
04/21/2023 | Metrocream | Metronidazole | Galderma Labs | Zydus |
04/24/2023 | Pepcid AC | Famotidine | Johnson & Johnson / McNeil | Alkem Labs |
04/25/2023 | Tazorac | Tazarotene | Allergan | Padagis |
04/26/2023 | Iressa | Gefitinib | AstraZeneca | Actavis |
04/26/2023 | Isuprel | Isoproterenol HCl | Bausch | Hikma |
04/26/2023 | Lyrica | Pregabalin | Upjohn | ACI |
04/26/2023 | Dexamethasone | Dexamethasone | Hikma | Bionpharma |
04/27/2023 | Thalomid | Thalidomide | Celgene | Natco |
04/27/2023 | Parafon Forte | Chlorzoxazone | Janssen | Acme Labs |
04/27/2023 | Intuniv | Guanfacine HCl | Takeda | Ajanta |
04/28/2023 | Treanda | Bendamustine HCl | Cephalon | Mylan |
04/28/2023 | Sabril | Vigabatrin | Lundbeck | Propel Pharma |
04/28/2023 | Delestrogen | Estradiol Valerate | Par Sterile | Xiromed |
05/01/2023 | Amitriptyline HCl | Amitriptyline HCl | Sandoz | Rubicon |
05/01/2023 | Aggrastat | Tirofiban HCl | Medicure | Eugia Pharma |
05/01/2023 | Celontin | Methsuximide | Parke Davis | Novitium Pharma |
05/01/2023 | Cosopt PF | Dorzolamide HCl / Timolol Maleate | Thea Pharma | Ingenus Pharms |
05/02/2023 | Ivanz | Ertapenem Sodium | Merck | Sun Pharm |
05/02/2023 | Cerdelga | Eliglustat Tartrate | Genzyme | Zenara |
05/03/2023 | Ofirmev | Acetaminophen | Mallinckrodt | HQ Specialty Pharma |
05/03/2023 | Carafate | Sucralfate | AbbVie | Zydus |
05/03/2023 | Edetate | Calcium Disodium Versenate | Bausch Health | Casper Pharma |
05/03/2023 | Cardene | Nicardipine HCl | Chiesi USA | Square Pharms |
05/04/2023 | Motpoly XR | Lacosamide | Aucta | Aucta |
05/04/2023 | Trokendi XR | Topiramate | Supernus | Par |
05/08/2023 | Zemuron | Rocuronium Bromide | Organon USA | Hong Kong |
05/08.2023 | Dibenzyline | Phenoxybenzamine HCl | Concordia | Aurobindo |
05/08/2023 | Timoptic in Ocudose | Timolol Maleate | Bausch and Lomb | Sentiss Pharma |
05/09/2023 | Ambien | Zolpidem Tartrate | Sanofi | Almatica |
05/09/2023 | Diamox | Acetazolamide | Teva | Aarksih Pharms |
05/09/2023 | Dexamethasone | Dexamethasone | Hikma | Novitium Pharma |
05/10/2023 | Propylthiouracil | Propylthiouracil | Dava Pharms | Macleods |
05/10/2023 | Toradol | Ketorolac Tromethamine | Roche Palo Alto | Caplin |
05/11/2023 | Abraxane | Paclitaxel | Abraxis | Teva |
05/11/2023 | Docetaxel | Docetaxel | Accord Healthcare | Mylan |
05/11/2023 | Revlimid | Lenalidomide | Celgene | Hetero Labs |
05/11/2023 | Furadantin | Nitrofurantoin | Casper Pharma | Aurobindo |
05/11/2023 | Theophylline | Theophylline | Bausch | Rhodes |
05/11/2023 | Fosamax | Alendronate Sodium | Merck | Novitium Pharma |
05/11/2023 | Bicnu | Carmustine | Avet Lifesciences | MSN |
05/11/2023 | Voltaren | Diclofenac Sodium | Novartis | Rubicon |
05/12/2023 | Lialda | Mesalamine | Takeda | Sinotherapeutics |
05/12/2023 | Neurontin | Gabapentin | Viatris | Laurus |
05/15/2023 | Aubagio | Teriflunomide | Sanofi | Natco |
05/15/2023 | Pepcid | Famotidine | Johnson & Johnson | Alkem |
05/15/2023 | Precedex | Dexmedetomidine HCl | Hospira | Amneal |
05/15/2023 | Banzel | Rufinamide | Esai | Micro Labs |
05/16/2023 | Emend | Fosaprepitant Dimeglumine | Merck | Piramal Critical |
05/16/2023 | Nalfon | Fenoprofen Calcium | Xspire Pharma | Misemer |
05/16/2023 | Akovaz | Ephedrine Sulfate | Exela Pharma | Zydus |
05/17/2023 | Lymphazurin | Isosulfan Blue | Covidien | AM Regent |
05/18/2023 | Effexor XR | Venlafaxine HCl | Upjohn | Granules |
05/19/2023 | Hemabate | Carboprost Tromethamine | Pfizer | Welding |
05/19/2023 | Amitriptyline HCl | Amitriptyline HCl | Sandoz | Graviti Pharms |
05/22/2023 | Alimta | Pemetrexed | Eli Lilly | Shilpa |
05/22/2023 | Fusilev | Levoleucovorin Calcium | Spectrum | Hainan Poly Pharm |
05/23/2023 | Brixadi | Bupremorphine | Braeburn | Braeburn |
05/23/2023 | Allegra | Fexofenadine HCl | Chattem Sanofi | Aurobindo |
05/23/2023 | Concerta | Methylphenidate HCl | Janssen | Alkem |
05/23/2023 | Haldol | Haloperidol Decanoate | Janssen | Mankind Pharma |
05/23/2023 | Lexiscan | Regadenoson | Astellas | Baxter |
05/24/2023 | Tapazole | Methimazole | King Pharms | Macleods |
05/24/2023 | Gilenya | Fingolimod HCl | Novartis | Bionpharma |
05/24/2023 | Zemuron | Rocuronium Bromide | Organon | Hikma |
05/24/2023 | Metronidazole | Metronidazole | Hospira | Amneal |
05/25/2023 | Orfadin | Nitisinone | Swedish Orphan | Zenara |
05/25/2023 | Hemabate | Carboprost Tromethamine | Pfizer | Eugia Pharma |
05/26/2023 | Renagel | Sevelamer HCl | Genzyme | Macleods Pharms |
05/26/2023 | Eliquis | Apixaban | Bristol-Myers Squibb | Aurobindo |
05/26/2023 | Vasostrict | Vasopressin | Endo / Par | Fresenius Kabi |
05/26/2023 | Timoptic | Timolol Maleate | Bausch and Lomb | Micro Labs |
05/30/2023 | Diastat Acudial | Diazepam | Bausch | Novel Labs |
05/30/2023 | Ocalvia | Obeticholic Acid | Intercept | Apotex |
05/30/2023 | Ocaliva | Obeticholic Acid | Intercept | Lupin |
05/30/2023 | Ocaliva | Obeticholic Acid | Intercept | MSN |
05/30/2023 | Rowasa | Mesalamine | Mylan Speciality | Encube |
05/31/2023 | Aczone | Dapsone | Almirall | Amneal |
05/31/2023 | Esbriet | Pirfenidone | Genentech | Apotex |
05/31/2023 | Iressa | Gefitinib | AstraZeneca | Natco |
05/31/2023 | Wellbutrin | Bupropion HCl | GlaxoSmithKline | Annora Pharma |
05/31/2023 | EC-Naprosyn | Naproxen | Atnahs Pharma | Tulex Pharms |
06/01/2023 | Benicar HCT | Olmesartan Medoxomil / Hydrochlorothiazide | Cosette | Macleods |
06/01/2023 | Cellcept | Mycophenolate Mofetil HCl | Roche | Bpi Labs |
06/01/2023 | Lyrica CR | Pregabalin | Upjohn | Sinotherapeutics |
06/01/2023 | Bentyl | Dicyclomine HCl | Allergan | Twi |
06/02/2023 | Corgard | Nadolol | USWM | Alembic |
06/02/2023 | Inspira | Eplerenone | Upjohn | Annora Pharma |
06/02/2023 | Arranon | Nelarabine | Sandoz | Nexus Pharms |
06/05/2023 | Treanda | Bendamustine HCl | Cephalon | Apotex |
06/05/2023 | Treanda | Bendamustine HCl | Cephalon | Kindos |
06/05/2023 | Reclast | Zoledronic Acid | Sandoz | Hong Kong |
06/05/2023 | Foscavir | Foscarnet Sodium | Clinigen Healthcare | Avet Lifesciences |
06/05/2023 | Treanda | Bendamustine HCl | Cephalon | Eugia Pharma |
06/06/2023 | Vesicare | Solifenacin Succinate | Astellas | Lannett |
06/06/2023 | Adcirca | Tadalafil | Eli Lilly | Zydus |
06/06/2023 | Aczone | Dapsone | Almirall (Allergan) | Acrux Dds |
06/06/2023 | Lovenox | Enoxaparin Sodium | Sanofi Aventis | Be Pharms |
06/06/2023 | Apriso | Mesalamine | Valeant Pharms | Amta |
06/07/2023 | Nexium | Esomeprazole Magnesium | AstraZeneca | Zydus |
06/07/2023 | Treanda | Bendamustine HCl | Cephalon | Nang Kuang Pharm |
06/07/2023 | Depo-Provera | Medroxyprogesterone Acetate | Pfizer | Amneal |
06/07/2023 | Precedex | Dexmedetomidine HCl | Hospira | Milla Pharms |
06/07/2023 | Mobic | Meloxicam | Boehringer Ingelheim | Ascent Pharms |
06/08/2023 | Fleqsuvy | Baclofen | Azurity | Slayback Pharma |
06/08/2023 | Colazel | Balsalazide Disodium | Valeant Pharms | Zydus |
06/09/2023 | Latuda | Lurasidone HCl | Sunovion | Macleods |
06/09/2023 | Esbriet | Pirfenidone | Genentech | Apotex |
06/09/2023 | Bridion | Sugammadex Sodium | Merck | Aspiro |
06/09/2023 | Ciprodex | Ciprofloxacin / Dexamethasone | Novartis | Akorn |
06/09/2023 | Nimbex | Cisatracurium Besylate | Abbvie | Caplin |
06/12/2023 | Athrotec | Diclofenac Sodium / Misoprostol | Pfizer | Zydus |
06/12/2023 | Chantix | Varenicline Tartrate | Pfizer | Zydus |
06/12/2023 | Toprol-XL | Metoprolol Succinate | Toprol | Granules |
06/13/2023 | Lonsurf | Tipiracil HCl / Trifluridine | Taiho Oncology | Natco |
06/13/2023 | Katerzia | Amlodipine Benzoate | Azurity | Amneal |
06/13/2023 | Sandostatin | Octreotide Acetate | Novartis | Gland Pharma |
06/13/2023 | Keppra | Levetiracetam | UCB | Granules |
06/14/2023 | Xadago | Safinamide Mesylate | MDD US | Aurobindo |
06/14/2023 | Nasonex 24 Hr Allegy | Mometasone Furoate | Perrigo | Amneal |
06/15/2023 | Bridion | Sugammadex Sodium | Merck | Mylan |
06/15/2023 | Hectorol | Doxercalciferol | Sanofi | Alembic |
06/15/2023 | Sodium Bicarbonate | Sodium Bicarbonate | Abbott Labs | Omnivium Pharms |
06/15/2023 | Hemabate | Carboprost Tromethamine | Pfizer | Alembic |
06/16/2023 | Solodyn | Minocycline HCl | Bausch | Zydus |
06/16/2023 | MetroGel-Vaginal | Metronidazole | Bausch | Encube |
06/16/2023 | Protonix | Pantoprazole Sodium | Wyeth | Dexcel |
06/16/2023 | Klor-Con | Potassium Chloride | Upsher-Smith | Rubicon |
06/16/2023 | Banzel | Rufinamide | Eisai | Aurobindo |
06/16/2023 | Pepcid | Famotidine | Johnson & Johnson | Appco |
06/16/2023 | Xylocaine | Lidocaine HCl | Fresenius Kabi | Mankind Pharma |
06/16/2023 | Lodoco | Colchicine | Agepha Pharma | Agepha Pharma |
06/20/2023 | Dibenzyline | Phenoxybenzamine HCl | Concordia | Rising |
06/20/2023 | Spiriva HandiHaler | Tiotropium Bromide | Boehringer Ingelheim | Lupin |
06/20/2023 | Glumetza | Metformin HCl | Santarus | Vgyaan |
06/20/2023 | Noxafil | Posaconazole | Merck | Welding |
06/20/2023 | Toradol | Ketorolac Tromethamine | Roche | Aspiro |
06/20/2023 | Trokendi XR | Topiramate | Supernus | Alkem Labs |
06/21/2023 | Samsca | Tolvaptana | Otsuka | MSN |
06/21/2023 | Nebcin | Tobramycin Sulfate | Eli Lilly | Eugia Pharma |
06/22/2023 | Adzenys SR-ODT | Amphetamine | Neos Theraps | Actavis |
06/22/2023 | Sandostatin | Octreotide Acetate | Novartis | Gland Pharma |
06/22/2023 | Migranal | Dihydroergotamine Mesylate | Bausch | Rubicon |
06/23/2023 | Lastacaft | Alcaftadine | AbbVie | Eugia Pharma |
06/23/2023 | Bridion | Sugammadex Sodium | Merck | Sandoz |
06/23/2023 | Sensorcaine | Bupivacaine Hydrochloride | Fresenius Kabi | Kindos |
06/26/2023 | Phenylphrine HCl | Phenoxybenzamine HCl | Hikma | Be Pharms |
06/27/2023 | Sinequan | Doxepin HCl | Pfizer | Micro Labs |
06/28/2023 | Vidaza | Azacitidine | Bristol-Myers Squibb | Jiangsu Hansoh |
06/29/2023 | Nuvaring | Etonogestrel / Ethinyl Estradiol | Merck | Xiromed |
06/29/2023 | Sabril | Vigabatrin | Lundbeck | Zenara |
06/29/2023 | Vancomycin HCl | Vancomycin HCl | Mylan | Hikma |
06/30/2023 | Nascobal | Cyanocobalamin | Endo | Lupin |
06/30/2023 | Activella | Estradiol / Norethindrone Acetate | Amneal | Aurobindo |
06/30/2023 | Faslodex | Fulvestrant | AstraZeneca | Eugia Pharma |
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