Abbreviated New Drug Applications and 505(b)(2) Applications
This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications.
| Reference Listed Drug | ANDA Holder | Generic Drug Name | ANDA Applicant(s) | Indication | Launch Date |
| Vancomycin HCl | Mylan | vancomycin HCl | Glenmark | Used to treat a variety of serious bacterial infections, especially those caused by Gram-positive bacteria that are resistant to other antibiotics. | 4/1/2025 |
| Trokendi XR | Supernus | topiramate | Par | Used to treat and prevent seizures in individuals with epilepsy. It is also prescribed to prevent migraine headaches in adults and adolescents aged 12 and older. | 4/1/2025 |
| Suprep Bowel Prep Kit | Sebela | sodium sulfate / potassium sulfate / magnesium sulfate | Camber | Used to cleanse the colon in preparation for colonoscopy in adult patients. | 4/3/2025 |
| CellCept | Roche | mycophenolate mofetil | Camber | Used for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants. | 4/9/2025 |
| Stromectol | Merck | ivermectin | Rubicon | Used to treat parasitic infections in humans and animals. | |
| Maxitrol | Harrow | neomycin / polymyxin b sulfates | Nordic Pharma | Used to treat and relieve bacterial eye infections. | 4/24/2025 |
| Percocet | Endo | oxycodone / acetaminophen | Elite | Used to relieve moderate to moderately severe pain. | 4/30/2025 |
| Vazculep | Exela | phenylephrine | Camber | Used to treat clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. | 5/1/2025 |
| Aptiom | Sumitomo | eslicarbazepine | Camber | Used to treat partial-onset seizures in patients 4 years of age and older. | 5/6/2025 |
| Aptiom | Sumitomo | eslicarbazepine | Apotex | Used to treat partial-onset seizures in patients 4 years of age and older. | 5/6/2025 |
| Aptiom | Sumitomo | eslicarbazepine | Dr. Reddy's Labs | Used to treat partial-onset seizures in patients 4 years of age and older. | 5/6/2025 |
| Aptiom | Sumitomo | eslicarbazepine | Ascend | Used to treat partial-onset seizures in patients 4 years of age and older. | 5/6/2025 |
| Aptiom | Sumitomo | eslicarbazepine | Torrent | Used to treat partial-onset seizures in patients 4 years of age and older. | 5/6/2025 |
| Aptiom | Sumitomo | eslicarbazepine | Lupin | Used to treat partial-onset seizures in patients 4 years of age and older. | 5/7/2025 |
| Qsymia | Vivus | phentermine / topimirate | Teva | Used for weight loss and long-term weight management for adults and children aged 12 and older who are considered obese (with a BMI of 30 kg/m² or greater). | 5/7/2025 |
| Jynarque | Otsuka | tolvaptan | Lupin | Used to treat slowing kidney function decline in adults with rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). | 5/13/2023 |
| Promacta | Novartis | eltrombopag | Camber | Used to treat thrombocytopenia—a serious condition affecting platelet counts—and aplastic anemia, which impacts the production of new blood cells | 5/14/2025 |
| Temodar | Merck | temozolomide | Camber | Used to treat newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment, anaplastic astrocytoma, and adults with refractory anaplastic astrocytoma. | 5/15/2025 |
| Epinephrine | Fresenius Kabi | epinephrine | Fresenius Kabi | Used to treat allergic reactions (Type 1), including anaphylaxis, in adults and pediatric patients and to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. | 5/20/2025 |
| Provay Blue | Proveparm | methylene blue | Nexus | Used to treat methemoglobinemia – a condition that affects the blood’s ability to carry oxygen. | 5/22/2025 |
| Tasigna | Novartis | nilotinib | Apotex | Used to treat certain types of leukemia, including newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia ("Ph+ CML") in chronic phase in adults and children aged 1 year and older. | 5/27/2025 |
| Fycompa | Esai | perampanel | Teva | Used to treat certain types of epilepsy. | 5/29/2025 |
| Byetta | Amylin | exenatide | Amneal | Used as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus. | 5/30/2025 |
