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 | 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 |
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
