Reserpine And Hydroflumethiazide

ANDA 88907, held by Par Pharm. Hydroflumethiazide; Reserpine.

As of Nov 15, 2026, ANDA 88907 (Reserpine And Hydroflumethiazide), held by Par Pharm, was first approved by FDA on Sep 20, 1985, with 3 approved supplements and 0 published complete response letters.

First approved: Sep 20, 1985
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Sep 20, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Reserpine And Hydroflumethiazide50MG;0.125MG · tablet;oral	Hydroflumethiazide; Reserpine	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Jun 7, 1996	Supplement 5Manufacturing	Approved	None posted
Mar 21, 1989	Supplement 4Labeling	Approved	None posted
Oct 7, 1986	Supplement 1Manufacturing	Approved	None posted
Sep 20, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 88907
Drugs@FDA: Overview at FDA
Company: Par Pharmaceutical

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