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 |
| Ciprodex | Sandoz | ciprofloxacin / dexamethasone | Upsher-Smith | Used as ear drops to treat bacterial infections. | 4/6/2026 |
| Lumigan | AbbVie | bimatoprost | Amneal | Used to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. | 4/9/2026 |
| ProAir HFA | Teva | albuterol | Amneal | Used to treat or prevent bronchospasm in patients 4 years of age and older with reversible obstructive airway disease, and for the prevention of exercise-induced bronchospasm in patients 4 years of age and older. | 4/14/2026 |
| QVAR | Teva | beclomethasone dipropionate | Amneal | Used for the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. | 4/14/2026 |
| Symbicort | AstraZeneca | budesonide / formoterol | Teva | Used to control symptoms of asthma and prevent symptoms such as wheezing in adults and children ages 6 and older. | 5/27/2026 |
| Januvia | Merck | sitagliptin | Teva | Used to lower blood sugar in adults with Type 2 diabetes. | 5/28/2026 |
| Januvia | Merck | sitagliptin | Apotex | Used to lower blood sugar in adults with Type 2 diabetes. | 6/3/2026 |
| Infuvite Adult | Sandoz | multivitamins | Apotex | Used to prevent vitamin deficiency in adults and children aged 11 and older receiving parenteral nutrition | 6/4/2026 |
| Romidepsin | Teva | romidepsin | Amneal | Used to treat cutaneous T-cell lymphoma. | 6/4/2026 |
| Edarbi | Azurity | azilsartan | Lupin | Used to treat hypertension in adults to lower blood pressure. | 6/17/2026 |
| Solu-Cortef | Pfizer | hydrocortisone | Apotex | Used short-term for severe autoimmune or inflammatory conditions. | 6/19/2026 |
| Infuvite Pediatric Injection | Sandoz | multiple vitamins injection | Apotex | Used to prevent vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition. | 6/24/2026 |
