BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | A203326 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition Amendment from Athyna Pharma LLC FDA-2025-P-5272 Athyna Pharma LLC submitted an amendment to its October 16, 2025 ANDA suitability petition for Buprenorphine Hydrochloride and Naloxone Hydrochloride sublingual tablets in new strengths of 16/4 mg, 12/3 mg, and 4/1 mg base, correcting the reference listed drug to NDA 020733 (Suboxone) and the refere | Suitability | 2025-11-07 | Open | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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