Methyldopate Hydrochloride

ANDA 71279, held by Am Regent. Methyldopate Hydrochloride.

As of Nov 15, 2026, ANDA 71279 (Methyldopate Hydrochloride), held by Am Regent, was first approved by FDA on Dec 2, 1987, with 9 approved supplements and 0 published complete response letters.

First approved: Dec 2, 1987
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Dec 2, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methyldopate Hydrochloride50MG/ML · injectable;injection	Methyldopate Hydrochloride	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Sep 5, 2001	Supplement 11Manufacturing	Approved	None posted
Jun 16, 1998	Supplement 10Labeling	Approved	None posted
Jan 29, 1998	Supplement 9Manufacturing	Approved	None posted
Sep 13, 1996	Supplement 8Labeling	Approved	None posted
Feb 28, 1996	Supplement 7Manufacturing	Approved	None posted
Mar 20, 1995	Supplement 5Manufacturing	Approved	None posted
Jun 20, 1994	Supplement 6Labeling	Approved	None posted
Mar 16, 1992	Supplement 4Labeling	Approved	None posted
Jul 7, 1990	Supplement 1Labeling	Approved	None posted
Dec 2, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 71279
Drugs@FDA: Overview at FDA
Company: Am Regent

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters