BUPROPION HYDROCHLORIDE | N022497 | TWI PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Ajanta Pharma USA Inc. FDA-2025-P-4778 Ajanta Pharma USA Inc. filed this citizen petition under 21 CFR 10.25 and 10.30 requesting that the FDA determine whether FORFIVO XL (bupropion hydrochloride) extended-release tablets 450 mg, approved under NDA 022497 and held by TWI Pharmaceuticals Inc., was voluntarily withdrawn from the market fo | 505(q) | 2025-10-06 | Withdrawn | Ajanta Pharma USA Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 7674479 | Aug 23, 2028 | — | — | Yes | — | — |