Methyldopa

NDA 18934, held by Chartwell Rx. Methyldopa.

As of Nov 13, 2026, NDA 18934 (Methyldopa), held by Chartwell Rx, was first approved by FDA on Jun 29, 1984, with 27 approved supplements and 0 published complete response letters.

First approved: Jun 29, 1984
Supplements approved: 27
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATION AND USAGE Hypertension.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 28 submissions below

Date	Submission	Status	Documents
Jun 29, 1984	Original application	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Methyldopa250MG · tablet;oral	Methyldopa	Discontinued
Methyldopa500MG · tablet;oral	Methyldopa	Discontinued

All 28 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 5, 1998	Supplement 42Labeling	Approved	None posted
Apr 28, 1998	Supplement 41Labeling	Approved	None posted
Jun 5, 1996	Supplement 40Labeling	Approved	None posted
Mar 27, 1995	Supplement 39Manufacturing	Approved	None posted
Feb 12, 1993	Supplement 38Labeling	Approved	None posted
Feb 23, 1991	Supplement 37Labeling	Approved	None posted
Sep 6, 1989	Supplement 36Labeling	Approved	None posted
Aug 12, 1988	Supplement 35Manufacturing	Approved	None posted
Aug 12, 1988	Supplement 34Manufacturing	Approved	None posted
Aug 12, 1988	Supplement 33Manufacturing	Approved	None posted
Jun 23, 1987	Supplement 27Manufacturing	Approved	None posted
Nov 19, 1986	Supplement 20Manufacturing	Approved	None posted
Nov 19, 1986	Supplement 19Manufacturing	Approved	None posted
Nov 19, 1986	Supplement 18Manufacturing	Approved	None posted
Nov 19, 1986	Supplement 17Manufacturing	Approved	None posted
Nov 19, 1986	Supplement 12Manufacturing	Approved	None posted
Nov 16, 1986	Supplement 23Manufacturing	Approved	None posted
Nov 16, 1986	Supplement 22Manufacturing	Approved	None posted
Nov 16, 1986	Supplement 21Manufacturing	Approved	None posted
Aug 22, 1986	Supplement 11Manufacturing	Approved	None posted
May 16, 1986	Supplement 10Manufacturing	Approved	None posted
Mar 17, 1986	Supplement 9Manufacturing	Approved	None posted
May 17, 1985	Supplement 8Manufacturing	Approved	None posted
May 17, 1985	Supplement 6Manufacturing	Approved	None posted
May 17, 1985	Supplement 5Manufacturing	Approved	None posted
May 17, 1985	Supplement 2Manufacturing	Approved	None posted
May 17, 1985	Supplement 1Manufacturing	Approved	None posted
Jun 29, 1984	Original application	Approved	None posted

Identifiers

Application: NDA 18934
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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