Methyldopate Hydrochloride

ANDA 70698, held by Hospira. Methyldopate Hydrochloride.

As of Nov 15, 2026, ANDA 70698 (Methyldopate Hydrochloride), held by Hospira, was first approved by FDA on Jun 15, 1987, with 18 approved supplements and 0 published complete response letters.

First approved: Jun 15, 1987
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Jun 15, 1987	Original application	Approved	None posted

Products

1 strengths and forms

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

All 19 submissions, including labeling and manufacturing supplements


Mar 12, 1999	Supplement 21Manufacturing	Approved	None posted
Mar 12, 1999	Supplement 19Manufacturing	Approved	None posted
Mar 12, 1999	Supplement 18Manufacturing	Approved	None posted
Aug 14, 1998	Supplement 20Labeling	Approved	None posted
Jan 7, 1997	Supplement 16Manufacturing	Approved	None posted
Oct 11, 1996	Supplement 15Labeling	Approved	None posted
May 10, 1995	Supplement 14Manufacturing	Approved	None posted
Nov 3, 1994	Supplement 13Labeling	Approved	None posted
Dec 22, 1993	Supplement 12Manufacturing	Approved	None posted
Mar 17, 1993	Supplement 10Labeling	Approved	None posted
Oct 30, 1992	Supplement 11Manufacturing	Approved	None posted
Apr 27, 1992	Supplement 9Manufacturing	Approved	None posted
Sep 9, 1991	Supplement 7Labeling	Approved	None posted
Aug 17, 1988	Supplement 5Manufacturing	Approved	None posted
Aug 17, 1988	Supplement 4Manufacturing	Approved	None posted
Aug 17, 1988	Supplement 3Manufacturing	Approved	None posted
Jul 15, 1988	Supplement 6Labeling	Approved	None posted
Nov 6, 1987	Supplement 1Labeling	Approved	None posted
Jun 15, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 70698
Drugs@FDA: Overview at FDA
Company: Hospira

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