BUPRENORPHINE HYDROCHLORIDE | A078633 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Athyna Pharma LLC FDA-2025-P-4987 Athyna Pharma LLC submitted a citizen petition under FDC Act section 505(j)(2)(C) requesting FDA approval to file an abbreviated new drug application (ANDA) for Buprenorphine Hydrochloride Sublingual Tablets in new strengths of 4 mg, 12 mg, and 16 mg (equivalent to base), which differ from the Refer | Suitability | 2025-10-09 | Open | Athyna Pharma LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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