Methyldopate Hydrochloride

ANDA 71812, held by Marsam Pharms LLC. Methyldopate Hydrochloride.

As of Nov 15, 2026, ANDA 71812 (Methyldopate Hydrochloride), held by Marsam Pharms LLC, was first approved by FDA on Dec 22, 1987, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 22, 1987
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
Dec 22, 1987	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


Feb 23, 1998	Supplement 7Labeling	Approved	None posted
Mar 27, 1990	Supplement 5Labeling	Approved	None posted
Dec 22, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 71812
Drugs@FDA: Overview at FDA
Company: Marsam Pharmaceuticals

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