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 |
| Zyprexa | Cheplapharm | olanzapine | Glenmark | Used to treat schizophrenia and bipolar disorder. | 7/6/2026 |
| Diazepam | RegCon | diazepam | Hikma | Used to manage anxiety disorders or for short-term relief of symptoms of anxiety; to relieve symptoms in acute alcohol withdrawal; as a premedication for relief of anxiety in patients undergoing surgical procedures or cardioversion. | 7/8/2026 |
| Bridion | Merck | sugammadex | B. Braun | Used to reverse neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. | 7/14/2026 |
| Janumet XR | Merck | sitagliptin / metformin | Par | Used to improve glycemic control in adults with type 2 diabetes mellitus. | 7/24/2026 |
| Bridion | Merck | sugammadex | Par | Used to reverse neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. | 7/29/2026 |
| Bridion | Merck | sugammadex | Camber | Used to reverse neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. | 7/30/2026 |
| Requip XL | Glaxo | ropinirole | Elite | Used to treat Parkinson's disease. | 8/4/2026 |
| Jynarque | Otsuka | tolvaptan | Apotex | Used to slow the progression of kidney decline in adults at risk of rapidly progressing ADPKD. | 8/6/2026 |
| Retin-A | Bausch | tretinoin | Alembic | Used to treat acne. | 8/12/2026 |
| Biaxin | AbbVie | clarithromycin | Solaris | Used to treat bacterial infections. | 8/13/2026 |
| Copaxone | Teva | glatiramer acetate | Upsher-Smith | Used to treat adult patients with relapsing forms of multiple sclerosis. | 8/20/2026 |
| Jynarque | Otsuka | tolvaptan | Teva | Used to slow the progression of kidney decline in adults at risk of rapidly progressing ADPKD. | 8/27/2026 |
| Advair Diskus | Glaxo | fluticasone / salmeterol | Aurobindo | Used to prevent asthma attacks and to treat chronic obstructive pulmonary disease (COPD). | 8/31/2026 |
| Rimso-50 | Mylan | dimethyl sulfoxide | Renova | Used to treat symptoms of interstitial cystitis (painful bladder syndrome). | 9/10/2026 |
| Nudexta | Otsuka | dextromethorphan / quinidine sulfate | Teva | Used to treat pseudobulbar affect (PBA). | 9/16/2026 |
| Somatuline Depot | Ipsen | lanreotide | Amneal | Used to treat acromegaly, advanced gastro-enteropancreatic neuroendocrine tumors (GEP-NETs), and carcinoid syndrome. | 9/18/2026 |
| Gilenya | Novartis | fingolimod | Alembic | Used to treat relapsing forms of multiple sclerosis. | 9/22/2026 |
