Declare ANDA May Be Submitted for Hydrocodone Bitartrate | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2001-P-0298

Declare ANDA May Be Submitted for Hydrocodone Bitartrate

Documents

Comments

Description

CLOSED DATE: 08/20/2001 Docket Status: CLOSED

Comment Period OpensJun 27, 2025

Type	Title	Posted	Comments	Status
Supporting Material	Background Materials re Citizen Petition from PAI, Pharmaceutical Associates, Inc.	Jun 27, 2025	--

BITARTRATE

ELIXIR

ANDA

ACETAMINOPHEN

325 MG

7.5 MG

CDER

CLOSED