BUPRENORPHINE HYDROCHLORIDE | N020732 | INDIVIOR INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Athyna Pharma LLC FDA-2025-P-5272 Athyna Pharma LLC filed this suitability petition requesting that the FDA declare Buprenorphine Hydrochloride and Naloxone Hydrochloride sublingual tablets in three new strengths (1.4 mg, 2.9 mg, and 5.7 mg) suitable for submission in an Abbreviated New Drug Application, referencing Indivior's appro | Suitability | 2025-10-17 | Open | Athyna Pharma LLC |
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 |
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2024-P-2909 The law firm Hyman, Phelps & McNamara, P.C., filed this Suitability Petition on behalf of a client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act to request that the FDA declare Buprenorphine Sublingual Tablets in 4 mg and 12 mg strengths suitable for submission as an A | Suitability | 2024-06-18 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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