Requests that the FDA declare that the drug product Buprenorphine Hydrochloride, Sublingual Tablets in the new strengths of eq 16 mg base, eq 12 mg base & eq 4 mg base, is suitable for submission in an Abbreviated New Drug Application. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-4987

Requests that the FDA declare that the drug product Buprenorphine Hydrochloride, Sublingual Tablets in the new strengths of eq 16 mg base, eq 12 mg base & eq 4 mg base, is suitable for submission in an Abbreviated New Drug Application.

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensOct 9, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Response Letter from FDA CDER to Athyna Pharma LLC	Feb 17, 2026	--

Keywords

CDER

Suitability Petition

Athyna Pharma LLC

declare that the drug product

Buprenorphine Hydrochloride Sublingual Tablets

in the new strengths of eq 16 mg base

eq 12 mg base and eq 4 mg base

is suitable for submission

Data from Regulations.gov