Methyldopate Hydrochloride

ANDA 70699, held by Hospira. Methyldopate Hydrochloride.

As of Nov 15, 2026, ANDA 70699 (Methyldopate Hydrochloride), held by Hospira, was first approved by FDA on Jun 15, 1987, with 9 approved supplements and 0 published complete response letters.

First approved: Jun 15, 1987
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
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 10 submissions, including labeling and manufacturing supplements


Aug 14, 1998	Supplement 10Labeling	Approved	None posted
Jul 22, 1997	Supplement 7Labeling	Approved	None posted
Jan 7, 1997	Supplement 8Manufacturing	Approved	None posted
Oct 22, 1996	Supplement 6Manufacturing	Approved	None posted
Jan 11, 1995	Supplement 5Labeling	Approved	None posted
Dec 22, 1993	Supplement 4Manufacturing	Approved	None posted
Jun 8, 1992	Supplement 3Labeling	Approved	None posted
Sep 10, 1991	Supplement 2Labeling	Approved	None posted
Jun 30, 1988	Supplement 1Labeling	Approved	None posted
Jun 15, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 70699
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