Methyldopa And Hydrochlorothiazide

ANDA 70265, held by Rising. Hydrochlorothiazide; Methyldopa.

As of Nov 15, 2026, ANDA 70265 (Methyldopa And Hydrochlorothiazide), held by Rising, was first approved by FDA on Jan 23, 1986, with 23 approved supplements and 0 published complete response letters.

First approved: Jan 23, 1986
Supplements approved: 23
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Jan 23, 1986	Original application	Approved	None posted

Products

2 strengths and forms


Methyldopa And Hydrochlorothiazide25MG;250MG · tablet;oral	Hydrochlorothiazide; Methyldopa	Discontinued
Methyldopa And Hydrochlorothiazide15MG;250MG · tablet;oral	Hydrochlorothiazide; Methyldopa	Discontinued

All 24 submissions, including labeling and manufacturing supplements


Aug 20, 2020	Supplement 47Labeling · Standard review	Approved	None posted
Dec 12, 2005	Supplement 28Labeling	Approved	None posted
Sep 5, 2001	Supplement 25Manufacturing	Approved	None posted
May 2, 2000	Supplement 24Manufacturing	Approved	None posted
Jan 24, 2000	Supplement 22Manufacturing	Approved	None posted
Nov 24, 1999	Supplement 23Labeling	Approved	None posted
Jun 16, 1998	Supplement 21Labeling	Approved	None posted
Feb 25, 1998	Supplement 20Manufacturing	Approved	None posted
Oct 27, 1997	Supplement 19Manufacturing	Approved	None posted
Jun 20, 1996	Supplement 18Manufacturing	Approved	None posted
Jun 20, 1996	Supplement 17Manufacturing	Approved	None posted
Jun 20, 1996	Supplement 16Labeling	Approved	None posted
Jun 20, 1996	Supplement 15Manufacturing	Approved	None posted
Jun 20, 1995	Supplement 14Manufacturing	Approved	None posted
Oct 22, 1993	Supplement 13Manufacturing	Approved	None posted
Apr 29, 1993	Supplement 11Labeling	Approved	None posted
Sep 26, 1991	Supplement 10Labeling	Approved	None posted
Jun 20, 1991	Supplement 9Labeling	Approved	None posted
Jan 25, 1991	Supplement 6Manufacturing	Approved	None posted
Jan 25, 1991	Supplement 5Manufacturing	Approved	None posted
Jan 31, 1990	Supplement 8Manufacturing	Approved	None posted
Nov 20, 1989	Supplement 7Labeling	Approved	None posted
Aug 7, 1986	Supplement 2Manufacturing	Approved	None posted
Jan 23, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70265
Drugs@FDA: Overview at FDA
Company: Rising 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