Methyldopate Hydrochloride

ANDA 70652, held by Abraxis Pharm. Methyldopate Hydrochloride.

As of Nov 15, 2026, ANDA 70652 (Methyldopate Hydrochloride), held by Abraxis Pharm, was first approved by FDA on Jun 3, 1986, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 3, 1986
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jun 3, 1986	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Sep 26, 1991	Supplement 8Labeling	Approved	None posted
Jun 3, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70652
Drugs@FDA: Overview at FDA
Company: Abraxis 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