Methyldopa And Hydrochlorothiazide

ANDA 71820, held by Teva. Hydrochlorothiazide; Methyldopa.

As of Nov 15, 2026, ANDA 71820 (Methyldopa And Hydrochlorothiazide), held by Teva, was first approved by FDA on Apr 8, 1988, with 4 approved supplements and 0 published complete response letters.

First approved: Apr 8, 1988
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Apr 8, 1988	Original application	Approved	None posted

Products

1 strengths and forms

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

All 5 submissions, including labeling and manufacturing supplements


Dec 7, 1995	Supplement 9Labeling	Approved	None posted
Sep 16, 1991	Supplement 7Labeling	Approved	None posted
Mar 25, 1991	Supplement 6Labeling	Approved	None posted
Mar 16, 1990	Supplement 2Labeling	Approved	None posted
Apr 8, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 71820
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceutical Industries

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