Methyldopa And Hydrochlorothiazide

ANDA 70958, held by Watson Labs. Hydrochlorothiazide; Methyldopa.

As of Nov 15, 2026, ANDA 70958 (Methyldopa And Hydrochlorothiazide), held by Watson Labs, was first approved by FDA on Feb 6, 1989, with 11 approved supplements and 0 published complete response letters.

First approved: Feb 6, 1989
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Feb 6, 1989	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methyldopa And Hydrochlorothiazide15MG;250MG · tablet;oral	Hydrochlorothiazide; Methyldopa	Discontinued

All 12 submissions, including labeling and manufacturing supplements


Aug 26, 1998	Supplement 11Labeling	Approved	None posted
Oct 8, 1996	Supplement 10Labeling	Approved	None posted
Aug 11, 1993	Supplement 9Labeling	Approved	None posted
May 6, 1993	Supplement 8Labeling	Approved	None posted
Aug 7, 1991	Supplement 4Manufacturing	Approved	None posted
May 24, 1991	Supplement 7Labeling	Approved	None posted
Apr 29, 1991	Supplement 2Manufacturing	Approved	None posted
Mar 19, 1991	Supplement 6Labeling	Approved	None posted
Jan 28, 1991	Supplement 5Manufacturing	Approved	None posted
Aug 17, 1989	Supplement 3Labeling	Approved	None posted
May 9, 1989	Supplement 1Labeling	Approved	None posted
Feb 6, 1989	Original application	Approved	None posted

Identifiers

Application: ANDA 70958
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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