ANDA Approvals - Fall 2024

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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 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
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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Attorney Advertising.

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