- Acumen Powered by Robins Kaplan LLP®
- Affirmative Recovery
- American Indian Law and Policy
- Antitrust and Trade Regulation
- Appellate Advocacy and Guidance
- Business Litigation
- Civil Rights and Police Misconduct
- Class Action Litigation
- Commercial/Project Finance and Real Estate
- Corporate Governance and Special Situations
- Corporate Restructuring and Bankruptcy
- Domestic and International Arbitration
- Entertainment and Media Litigation
- Health Care Litigation
- Insurance and Catastrophic Loss
- Intellectual Property and Technology Litigation
- Mass Tort Attorneys
- Medical Malpractice Attorneys
- Personal Injury Attorneys
- Telecommunications Litigation and Arbitration
- Wealth Planning, Administration, and Fiduciary Disputes
Acumen Powered by Robins Kaplan LLP®
Ediscovery, Applied Science and Economics, and Litigation Support Solutions
-
December 5, 2024Jake Holdreith Named to Twin Cities Business Top 100
-
December 4, 2024Robins Kaplan Obtains $10.5 Million Post-Verdict in Landmark Aerosol Dust Remover Abuse Case
-
December 2, 2024Robins Kaplan LLP Announces 2025 Partners
-
December 11, 20242024 Year in Review: eDiscovery and Artificial Intelligence
-
December 12, 2024Strategies for Licensing AI: A Litigation Perspective
-
December 2024A Landmark Victory for Disabled Homeless Veterans: Q&A with the Trial Team
-
November 8, 2024Trademark tensions on the track: Court upholds First Amendment protections in Haas v. Steiner
-
November 8, 2024Destination Skiing And The DOJ's Mountain Merger Challenge
-
September 16, 2022Uber Company Systems Compromised by Widespread Cyber Hack
-
September 15, 2022US Averts Rail Workers Strike With Last-Minute Tentative Deal
-
September 14, 2022Hotter-Than-Expected August Inflation Prompts Massive Wall Street Selloff
Find additional firm contact information for press inquiries.
Find resources to help navigate legal and business complexities.
Read our attorneys' take on the latest news and trends in the legal and business industries.
ANDA Approvals
New Drug Applications and 505(b)(2) Applications
Third Quarter
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 |
GENERICally Speaking Hatch Waxman Bulletin
GENERICally Speaking Hatch Waxman Bulletin
READ MORE Related Publications
September 18, 2024
Astellas Pharma, Inc. v. Sandoz Inc.
GENERICally Speaking Hatch Waxman Bulletin
September 9, 2024
Purdue Pharma L.P v. Accord Healthcare Inc.
GENERICally Speaking Hatch Waxman Bulletin
September 4, 2024
Exeltis USA, Inc. v. Lupin Ltd.
GENERICally Speaking Hatch Waxman Bulletin
August 28, 2024
Teva Branded Pharm. Products R&D, Inc. v. Deva Holding A.S.
GENERICally Speaking Hatch Waxman Bulletin
August 13, 2024
Allergan USA, Inc. v. MSN Labs. Private Ltd.
GENERICally Speaking Hatch Waxman Bulletin
Related News
October 14, 2022
September 9, 2022
Back to Top
Any information that you send us in an e-mail message should not be confidential or otherwise privileged information. Sending us an e-mail message will not make you a client of Robins Kaplan LLP. We do not accept representation until we have had an opportunity to evaluate your matter, including but not limited to an ethical evaluation of whether we are in a conflict position to represent you. Accordingly, the information you provide to us in an e-mail should not be information for which you would have an expectation of confidentiality.
If you are interested in having us represent you, you should call us so we can determine whether the matter is one for which we are willing or able to accept professional responsibility. We will not make this determination by e-mail communication. The telephone numbers and addresses for our offices are listed on this page. We reserve the right to decline any representation. We may be required to decline representation if it would create a conflict of interest with our other clients.
By accepting these terms, you are confirming that you have read and understood this important notice.
If you are interested in having us represent you, you should call us so we can determine whether the matter is one for which we are willing or able to accept professional responsibility. We will not make this determination by e-mail communication. The telephone numbers and addresses for our offices are listed on this page. We reserve the right to decline any representation. We may be required to decline representation if it would create a conflict of interest with our other clients.
By accepting these terms, you are confirming that you have read and understood this important notice.