Methyldopate Hydrochloride

ANDA 70291, held by Baxter Hlthcare. Methyldopate Hydrochloride.

As of Nov 15, 2026, ANDA 70291 (Methyldopate Hydrochloride), held by Baxter Hlthcare, was first approved by FDA on Jul 1, 1986, with 9 approved supplements and 0 published complete response letters.

First approved: Jul 1, 1986
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
Jul 1, 1986	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


Nov 14, 1996	Supplement 10Labeling	Approved	None posted
Feb 8, 1994	Supplement 9Labeling	Approved	None posted
Jan 21, 1992	Supplement 5Manufacturing	Approved	None posted
Jan 21, 1992	Supplement 6Manufacturing	Approved	None posted
Sep 10, 1991	Supplement 8Labeling	Approved	None posted
Aug 7, 1991	Supplement 4Manufacturing	Approved	None posted
Mar 1, 1991	Supplement 7Labeling	Approved	None posted
Jun 15, 1988	Supplement 3Labeling	Approved	None posted
Nov 3, 1986	Supplement 2Manufacturing	Approved	None posted
Jul 1, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70291
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

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