Methyldopa And Hydrochlorothiazide

ANDA 72508, held by Dava Pharms Inc. Hydrochlorothiazide; Methyldopa.

As of Nov 15, 2026, ANDA 72508 (Methyldopa And Hydrochlorothiazide), held by Dava Pharms Inc, was first approved by FDA on Jun 2, 1989, with 10 approved supplements and 0 published complete response letters.

First approved: Jun 2, 1989
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jun 2, 1989	Original application	Approved	None posted

Products

1 strengths and forms

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

All 11 submissions, including labeling and manufacturing supplements


Apr 14, 1998	Supplement 10Labeling	Approved	None posted
Jun 23, 1997	Supplement 9Labeling	Approved	None posted
Feb 21, 1996	Supplement 7Manufacturing	Approved	None posted
Feb 21, 1996	Supplement 8Manufacturing	Approved	None posted
Jan 13, 1995	Supplement 6Labeling	Approved	None posted
Apr 14, 1993	Supplement 5Labeling	Approved	None posted
Nov 16, 1992	Supplement 3Manufacturing	Approved	None posted
Nov 16, 1992	Supplement 4Manufacturing	Approved	None posted
Apr 2, 1992	Supplement 2Labeling	Approved	None posted
Mar 6, 1991	Supplement 1Manufacturing	Approved	None posted
Jun 2, 1989	Original application	Approved	None posted

Identifiers

Application: ANDA 72508
Drugs@FDA: Overview at FDA
Company: DAVA Pharmaceuticals

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