Methyldopa And Hydrochlorothiazide

ANDA 70183, held by Chartwell Rx. Hydrochlorothiazide; Methyldopa.

As of Nov 15, 2026, ANDA 70183 (Methyldopa And Hydrochlorothiazide), held by Chartwell Rx, was first approved by FDA on Jan 15, 1986, with 19 approved supplements and 0 published complete response letters.

First approved: Jan 15, 1986
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Jan 15, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methyldopa And Hydrochlorothiazide25MG;250MG · tablet;oral	Hydrochlorothiazide; Methyldopa	Discontinued

All 20 submissions, including labeling and manufacturing supplements


Aug 20, 2020	Supplement 29Labeling · Standard review	Approved	None posted
Aug 6, 2020	Supplement 28Labeling · Standard review	Approved	None posted
Nov 25, 1998	Supplement 23Manufacturing	Approved	None posted
Nov 25, 1998	Supplement 22Manufacturing	Approved	None posted
Aug 19, 1996	Supplement 19Manufacturing	Approved	None posted
Apr 2, 1996	Supplement 20Labeling	Approved	None posted
Jan 24, 1994	Supplement 18Manufacturing	Approved	None posted
Aug 2, 1993	Supplement 17Labeling	Approved	None posted
Apr 30, 1993	Supplement 16Labeling	Approved	None posted
Jan 31, 1992	Supplement 15Labeling	Approved	None posted
Sep 15, 1989	Supplement 14Labeling	Approved	None posted
Feb 17, 1988	Supplement 12Manufacturing	Approved	None posted
Feb 17, 1988	Supplement 11Manufacturing	Approved	None posted
Jan 29, 1988	Supplement 9Manufacturing	Approved	None posted
Dec 11, 1986	Supplement 2Manufacturing	Approved	None posted
Dec 4, 1986	Supplement 6Manufacturing	Approved	None posted
Dec 4, 1986	Supplement 5Manufacturing	Approved	None posted
Dec 4, 1986	Supplement 4Manufacturing	Approved	None posted
Dec 4, 1986	Supplement 3Manufacturing	Approved	None posted
Jan 15, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70183
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