Request that the FDA declare that Methylnaltrexone Bromide Tablets, 450 mg, is suitable for submission as an ANDA | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-6022

Request that the FDA declare that Methylnaltrexone Bromide Tablets, 450 mg, is suitable for submission as an ANDA

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensNov 12, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Completeness Assessment Correspondence	Dec 1, 2025	--

Keywords

CDER

Suitability Petition

Wishmen Lifesciences Private Limited

declare that Methylnaltrexone Bromide Tablets

450 mg, is suitable for submission as an ANDA

CLOSED

Data from Regulations.gov