ZOLPIDEM TARTRATE | N019908 | COSETTE PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Senores Pharmaceuticals, Inc FDA-2025-P-2078 Senores Pharmaceuticals, Inc. filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an Abbreviated New Drug Application for Zolpidem Tartrate Tablet 7.5 mg, a strength that differs from the Reference Listed Drug AMBIE | Suitability | 2025-07-01 | Open | Senores Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.