Methyldopa And Hydrochlorothiazide

ANDA 72507, held by Dava Pharms Inc. Hydrochlorothiazide; Methyldopa.

As of Nov 15, 2026, ANDA 72507 (Methyldopa And Hydrochlorothiazide), held by Dava Pharms Inc, was first approved by FDA on Jun 2, 1989, with 9 approved supplements and 0 published complete response letters.

First approved: Jun 2, 1989
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 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 Hydrochlorothiazide15MG;250MG · tablet;oral	Hydrochlorothiazide; Methyldopa	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Feb 17, 1999	Supplement 9Manufacturing	Approved	None posted
Apr 14, 1998	Supplement 8Labeling	Approved	None posted
Jun 23, 1997	Supplement 7Labeling	Approved	None posted
Feb 12, 1996	Supplement 6Manufacturing	Approved	None posted
Feb 12, 1996	Supplement 5Manufacturing	Approved	None posted
Jan 13, 1995	Supplement 4Labeling	Approved	None posted
Apr 14, 1993	Supplement 3Labeling	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 72507
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