Requests that the FDA declare that the drug product, Buprenorphine Hydrochloride & Naloxone Hydrochloride, Sublingual Tablets in the new strengths 16/4 mg eq to base,12/3 mg eq to base & 4/1 mg eq to base, is suitable for submission in an ANDA | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-5272

Requests that the FDA declare that the drug product, Buprenorphine Hydrochloride & Naloxone Hydrochloride, Sublingual Tablets in the new strengths 16/4 mg eq to base,12/3 mg eq to base & 4/1 mg eq to base, is suitable for submission in an ANDA

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensOct 17, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Final Response Letter from FDA CDER to Athyna Pharma LLC	Mar 26, 2026	--

Keywords

CDER

Suitability Petition

Athyna Pharma LLC

Requests that the FDA declare that the

drug product, Buprenorphine Hydrochloride

& Naloxone Hydrochloride, Sublingual Tablets

in the new strengths 16/4 mg eq to base,

12/3 mg eq to base & 4/1 mg eq to base, is

Data from Regulations.gov