Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant ANDA # 07/01/2024 Octreoscan Indium In-111 Pentetreotide Kitanda   Curium Sun Pharm 212785 07/01/2024 Exparel Bupivacaine Liposome  Pacira Pharms Hengrui Pharma 214348 07/01/2024 Atropine Sulphate Atropine Sulfate Rising Somerset 215618 07/01/2024 Bentyl Dicyclomine HCl   Allergan Annora Pharma 218018 07/01/2024 Silenor Doxepin HCl  Currax Ajanta 218564 07/02/2024 Tamiflu Oseltamivir Phosphate  Roche Oryza 217303 07/03/2024 Atropine Sulphate Atropine Sulfate Accord Healthcare Somerset 215969 07/03/2024 Istalol Timolol Maleate Bausch and Lomb Somerset 216653 07/03/2024 Timoptic Timolol Maleate Bausch and Lomb Somerset 217764 07/05/2024 Restasis Cyclosporine AbbVie Saptalis Pharms 211943 07/05/2024 Zinc Sulfate Zinc Sulfate American Regent Nivagen Pharms 214597 07/05/2024 Glucophage XR Metformin HCl   EMD Serono Harman Finochem 218673 07/08/2024 Prolensa Bromfenac Sodium  Bausch and Lomb Apotex 207334 07/08/2024 Librax Chlordiazepoxide HCL / Clidinium Bromide   Bausch Health Winder Labs 212344 07/08/2024 Prolensa Bromfenac Sodium  Bausch and Lomb Alembic 214340 07/08/2024 Endari L-Glutamine  Emmaus Medical Novitium Pharma 215647 07/08/2024 Calcium Chloride Calcium Chloride Hospira Amneal 217524 07/09/2024 Entresto Sacubitril / Valsartan   Novartis Zydus 213719 07/09/2024 Nymalize Nimodipine Azurity Annora 216937 07/09/2024 Succinylcholine Chloride   Succinylcholine Chloride   Hikma Steriscience 217873 07/10/2024 Cerdelga Eliglustat Tartrate  Genzyme Apotex 212425 07/10/2024 Robinul Glycopyrrolatea Casper Pharma Quagen 212696 07/10/2024 Loteprednol Etabonate  Loteprednol Etabonate  Bausch and Lomb Padagis 215203 07/10/2024 Vibisone Cyanocobalamin  Fresenius Kabi Mankind Pharma 217839 07/11/2024 Vasostrict Vasopressin Endo/Par Long Grove N217766 07/11/2024 Benicar HCT Hydrochlorothiazide / Olmesartan Medoxomil   Cosette Alkem Labs 207037 07/11/2024 Trokendi XR Topiramate Supernus Lupin 215561 07/11/2024 Oracea Doxycycline Galderma Labs Apotex 217170 07/11/2024 Potassium Phosphates  Potassium Phosphates  Fresenius Kabi Somerset 217726 07/12/2024 Renvela Sevelamer Carbonate Sanofi Genzyme  InvaGen Pharms 206234 07/12/2024 Zemuron Rocuronium Bromide  Organon Shandong 215684 07/12/2024 Divigel Estradiol   Vertical Pharms Amneal 216055 07/12/2024 Divigel Estradiol   Vertical Pharms Solaris Pharma 217863 07/12/2024 Travatan Z Travoprost  Sandoz Gland Pharma 218159 07/15/2024 Suprep Bowel Prep Kit Sodium Sulfate / Potassium Sulfate / Magnesium Sulfate Braintree Labs Lannett 209941 07/15/2024 Tazorac Tazarotene   Allergan Padagis 217075 07/16/2024 Doxil (Liposomal) Doxorubicin HCl (Liposomal)   Baxter Healthcare Fordoz 215178 07/16/2024 Synthroid Levothyroxine Sodium  AbbVie Aurobindo 216414 07/16/2024 Topamax Topiramate  Janssen Glenmark 217869 07/17/2024 Zinc Sulfate Zinc Sulfate American Regent Somerset 216135 07/18/2024 Zituvimet XR Metformin HCl / Sitagliptin Merck Zydus N216778 07/18/2024 Jalyn Dutasteride / Tamsulosin Hydrochloride  Waylis Therapeutics Aurobindo 213300 07/18/2024 Halaven Eribulin Mesylate  Eisai Long Grove 214850 07/18/2024 Noxafil Posaconazole Merck Aurobindo 217119 07/18/2024 Diazepam Diazepam Merck Dr. Reddy’s Labs 218422 07/18/2024 Akovaz Ephedrine Sulfate   Exela Pharma Caplin 219050 07/22/2024  Amrix Cyclobenzaprine HCl  Teva Macleods 207314 07/22/2024 Merrem Meropenem  Pfizer Qilu 216424 07/22/2024 Thiola EC Tiopronin Mission Pharmacal Teva 216456 07/22/2024 Zemuron Rocuronium Bromide   Organon Steriscience 217092 07/22/2024 Olumiant Baricitinib  Eli Lilly Aurobindo 217542 07/22/2024 Pronestyl Procainamide HCl   Apothecon Gland 218135 07/22/2024 Diovan Valsartan Novartis Zydus 218991 07/23/2024 Carafate Sucralfate   AbbVie Hikma 212769 07/23/2024 Chantix Varenicline Tartrate   PF Prism Slate Run 217115 07/23/2024 Vibramycin Doxycycline Hyclate   Pfizer Acic Pharms 217854 07/23/2024 Prolixin Fluphenazine HCl  Apothecon Alembic 218173 07/24/2024 Emtresto Sacubitril / Valsartan   Novartis MSN 213748 07/25/2024 Kaletra Lopinavir and Ritonavir   AbbVie Macleods 204739 07/26/2024 Toprol-XL Metoprolol Succinate   Toprol Zhejiang Jutai Pharm 214110 07/29/2024 Prolensa Bromfenac Sodium  Bausch and Lomb Amneal 210962 07/30/2024 Naropin Ropivacaine HCl   Fresenius Kabi Kindos 218713 08/01/2024 Lodine Etodolac   Wyeth Ipca Labs 205448 08/01/2024 Daptomycin Daptomycin  Sagent Pharms Fresenius Kabi 213396 08/01/2024 Ocuflox Ofloxacin  Allergan Somerset 213597 08/01/2024 Pantoprazole Sodium   Pantoprazole Sodium   Hikma Fresenius Kabi 216021 08/01/2024 Arranon Nelarabine  Sandoz Alembic 218554 08/02/2024 Vagifem Estradiol  Novo Nordisk Aurobindo 216550 08/02/2024 Pred Forte Prednisolone Acetate  AbbVie Lupin 216935 08/05/2024 Polytrim Trimethoprim Sulfate / Polymyxin B Sulfate   Allergan Somerset 211572 08/05/2024 Lexiscan Regadenoson Astellas GE Healthcare 215955 08/05/2024 Soriatane Acitretin  Stiefel Labs Alembic 217774 08/05/2024 Diovan Valsartan Novartis Zenara 218169 08/06/2024 Isuprel Isoproterenol HCl  Bausch Health Somerset 211590 08/06/2024 Pepcid Famotidine   Bausch MSN 217400 08/07/2024 Crexont Carbidopa / Levodopa Impax Impax N217186 08/07/2024 Ingrezza Valbenazine Tosylate Neurocrine Zydus 216137 08/07/2024 Timoptic Timolol Maleate Bausch and Lomb Caplin 218460 08/07/2024 Zanaflex Tizanidine HCl   Legacy Pharma Graviti Pharms 218920 08/08/2024 Desyrel Trazodone HCl   Pragma Granules 218988 08/09/2024 Alcaine Proparacaine HCl   Novartis Somerset 215816 08/09/2024 Alphagan P Brimonidine Tartrate   AbbVie Somerset 216906 08/12/2024 Pradaxa Dabigatran Etexilate Mesylate  Boehringer Ingelheim MSN 213879 08/12/2024 Pradaxa Dabigatran Etexilate Mesylate   Boehringer Ingelheim Alembic 215233 08/12/2024 Sterile Water Sterile Water  B Braun Fresenius Kabi 216123 08/12/2024 Midazolam in 0.9% Sodium Chloride Midazolam in 0.9% Sodium Chloride  InfoRLife Gland Pharma 218993 08/13/2024 Pradaxa Dabigatran Etexilate Mesylate   Boehringer Ingelheim Hetero Labs 207961 08/13/2024 Cialis Tadalafil  Eli Lilly Fourrts Labs 217606 08/14/2024 Urso 250 Ursodiol  Allergan Epic Pharma 214717 08/14/2024 Bepreve Bepotastine Besilate   Bausch and Lomb Somerset 217770 08/15/2024 Naropin Ropivacaine HCl   Fresenius Kabi Hikma 211907 08/15/2024 Propofol Propofol   Fresenius Kabi Amneal 217525 08/15/2024 Tranexamic Acid Tranexamic Acid  Exela Pharma Fresenius Kabi 218242 08/16/2024 Brilinta Ticagrelor  AstraZeneca Prinston 208599 08/16/2024 Colestid Colestipol HCl   Pfizer Edenbridge Pharms 217667 08/16/2024 Tykerb Lapatinib Ditosylate  Novartis Teva 217968 08/19/2024 Cuvposa Glycopyrrolate  Merz Granules 214735 08/19/2024 Arixtra Fondaparinux Sodium Mylan Hangzhou Zhongmei 216493 08/19/2024 Cupric Sulfate Cupric Sulfate  Abraxis Apotex 218745 08/20/2024 Livalo Pitavastatin Calcium  Kowa Amneal 205961 08/20/2024 Onexton Clindamycin Phosphate / Benzoyl Peroxide   Bausch Padagis 209610 08/20/2024 Tepadina Thiotepa Adienne Beloteca 217559 08/20/2024 Lucemyra Lofexidine HCl   US World Meds Indoco 218613 08/21/2024 Apresoline Hydralazine HCl   Novartis Macleods 211010 08/21/2024 Latuda Lurasidone HCl   Sunovion Pharms Annora Pharma 218174 08/22/2024 Asacol Mesalamine   AbbVie Teva 213191 08/22/2024 Entresto Sacubitril / Valsartan   Novartis Torrent 213604 08/22/2024 Luxiq Betamethasone Valerate   Norvium Bioscience Alembic 215832 08/22/2024 Tiglutik Kit Riluzole   Italfarmaco Alkem Labs 216035 08/22/2024 Lexiscan Regadenoson   Astellas Indies Pharma 218054 08/22/2024 Apriso Mesalamine   Salix Novast Labs 218410 08/23/2024 Temodar Temozolomide   Merck Hetero Labs 210030 08/23/2024 Acetaminophen / Ibuprofen Acetaminophen / Ibuprofen   Haleon Dr. Reddy’s Labs 218247 08/26/2024 Velcade Bortezomib Takeda Shilpa N212782 08/26/2024 Relistor Methylnaltrexone Bromide   Salix Actavis 208112 08/26/2024 Alphagan P Brimonidine Tartrate   AbbVie Lupin 213215 08/26/2024 Aczone Dapsone   Almirall Acrux DDS 213636 08/26/2024 Gocovri Amantadine HCl   Adamas Zydus 214897 08/27/2024 Amrix Cyclobenzaprine HCl   Teva Novast Labs 214732 08/27/2024 Nimbex Cisatracurium Besylate Preservative Free  AbbVie Hainan Poly 216539 08/27/2024 Detrol LA Tolterodine Tartrate   Upjohn Unichem 216917 08/27/2024 Desyrel Trazodone HCl   Pragma Graviti Pharms 217740 08/28/2024 Cuvposa Glycopyrrolate   Merz Chartwell RX 216368 08/28/2024 Nuedexta Dextromethorphan Hydrobromide / Quinidine Sulfate   Avanir Pharms Hetero Labs 218426 08/29/2024 Cubicin Daptomycin   Cubist Biocon Pharma 217215 08/29/2024 Transderm Scop Scopolamine   Baxter Healthcare Zydus 217893 08/30/2024 Prevymis Letermovir Merck Merck 219104 08/30/2024 Entresto Sacubitril / Valsartan   Novartis Biocon Pharma 213680 09/03/2024 Tradjenta Linagliptin Boehringer Ingelheim Invagen 208423 09/04/2024 Vimpat Lacosamide UCB Unichem 213109 09/04/2024 Albenza Albendazole Impax Labs Alembic 215652 09/05/2024 Corlanor Ivabradine HCl Amgen Bionpharma 213276 09/05/2024 Solu-Cortef Hydrocortisone Sodium Succinate Pharmacia and Upjohn Cipla 214050 09/05/2024 Theo-Dur Theophylline Schering-Plough Strides 215312 09/05/2024 Arranon Nelarabine Sandoz XGen Pharms 216510 09/06/2024 Targretin Bexarotene Valeant Ascent 208628 09/06/2024 Klor-Con Potassium Chloride Upsher Smith Macleods 212987 09/06/2024 Adrenalin Epinephrine Endo AM Regent 217192 09/06/2024 Nicardipine HCl Nicardipine HCl Hikma Chengdu Shuode 217548 09/09/2024 Gralise Gabapentin Almatica Abon Pharms 203643 09/09/2024 Dostinex Cabergoline Pfizer Welding 218109 09/10/2024 Zyrtec-D 12 Hour Cetirizine HCl / Pseudoephedrine HCl Johnson & Johnson Unichem 210507 09/10/2024 Combigan Brimonidine Tartrate / Timolol Maleate AbbVie Somerset 216114 09/11/2024 Pradaxa Dabigatran Etexilate Mesylate Boehringer Ingelheim Alkem 208040 09/11/2024 Busulfex Busulfan Otsuka Prinston 215235 09/11/2024 Revlimid Lenalidomide Bristol-Myers Squibb Novugen 217281 09/12/2024 Flexeril Cyclobenzaprine HCl Janssen Graviti Pharms 218936 09/13/2024 Tarceva Erlotinib HCl OSI Pharmaceuticals Hikma 203843 09/13/2024 Compazine Prochlorperazine Edisylate GlaxoSmithKline Somerset 212257 09/13/2024 Fluoxetine HCl Fluoxetine HCl TWi Strides 212683 09/13/2024 Arranon Nelarabine Sandoz MSN 216948 09/16/2024 Timoptic-XE Timolol Maleate Bausch and Lomb Somerset 210640 09/16/2024 Entresto Sacubitril / Valsartan Novartis Alkem Labs 213764 09/16/2024 Rapamune Sirolimus PF Prism CV Hetero Labs 215080 09/16/2024 Nizoral Ketoconazole Janssen Novitium 218498 09/17/2024 Metyrosine Metyrosine Bausch Health Leading 215541 09/17/2024 Minipress Prazosin HCl Pfizer MSN 216727 09/17/2024 Steglatro Ertugliflozin Merck Hetero Labs 217071 09/17/2024 Bumex Bumetanide Validus Lupin 217153 09/17/2024 Dexamethasone Dexamethasone Hikma Corepharma 218372 09/18/2024 Bumex Bumetanide Validus Appco 212931 09/19/2024 Nubain Nalbuphine HCl Endo Somerset 216049 09/19/2024 Nubain Nalbuphine HCl Endo Somerset 216050 09/19/2024 Vasotec Enalapril Maleate Bausch Health Unique Pharm 218531 09/19/2024 Bumex Bumetanide Validus Qilu Pharm Hainan 219116 09/20/2024 Evoxac Cevimeline HCl Cosette Macleods 206808 09/20/2024 D.H.E. 45 Dihydroergotamine Mesylate Bausch Health Cipla 212334 09/20/2024 Miacalcin Calcitonin Salmon Mylan Cipla 213766 09/20/2024 Plavix Clopidogrel Bisulfate Sanofi Aventis MSN 215388 09/23/2024 Travatan Z Travoprost Sandoz Somerset 217228 09/24/2024 Nicardipine HCl Nicardipine HCl Hikma Cipla 215592 09/24/2024 Fluorouracil Fluorouracil Spectrum Pharms Kindos 216494 09/24/2024 Dexmedetomidine HCl Dexmedetomidine HCl HQ Specialty Somerset 218112 09/24/2024 Chlorpromazine HCl Chlorpromazine HCl Hikma Deva 218229 09/24/2024 Anectine Succinylcholine Chloride Sandoz Baxter Healthcare 218878 09/25/2024 Copaxone Glatiramer Acetate Teva Synthon Pharms 203857 09/25/2024 Copaxone Glatiramer Acetate Teva Synthon Pharms 206873 09/26/2024 Lamictal Lamotrigine GlaxoSmithKline Ipca Labs 204499 09/26/2024 Xtandi Enzalutamide Astellas Zydus 209667 09/26/2024 Pomalyst Pomalidomide Bristol-Myers Squibb Hetero Labs 210236 09/26/2024 Amicar Aminocaproic Acid Hikma MSN 215100 09/26/2024 Cellcept Mycophenolate Mofetil Roche Palo Aurobindo 218227 09/26/2024 Invega Paliperidone Janssen Alembic 218330 09/26/2024 Symmetrel Amantadine HCl Endo Pharms Zhejiang Jutai 218598 09/27/2024 Denavir Penciclovir Mylan Padagis 212368 09/30/2024 Slynd Drospirenone Exeltis USA Lupin 216936 09/30/2024 Compazine Prochlorperazine Maleate GlaxoSmithKline Leading 218912



Source link

Leave a Comment

Your email address will not be published. Required fields are marked *