Methyldopate Hydrochloride

ANDA 72974, held by Teva Parenteral. Methyldopate Hydrochloride.

As of Nov 15, 2026, ANDA 72974 (Methyldopate Hydrochloride), held by Teva Parenteral, was first approved by FDA on Nov 22, 1991, with 2 approved supplements and 0 published complete response letters.

First approved: Nov 22, 1991
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Nov 22, 1991	Original application	Approved	None posted

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements


Mar 20, 2000	Supplement 2Labeling	Approved	None posted
Jun 3, 1993	Supplement 1Labeling	Approved	None posted
Nov 22, 1991	Original application	Approved	None posted

Identifiers

Application: ANDA 72974
Drugs@FDA: Overview at FDA
Company: Teva Parenteral Medicines

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