Minizide

NDA 17986, held by Pfizer. Polythiazide; Prazosin Hydrochloride.

As of Nov 13, 2026, NDA 17986 (Minizide), held by Pfizer, was first approved by FDA on Jun 13, 1980, with 12 approved supplements and 0 published complete response letters.

First approved: Jun 13, 1980
Review: Standard
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Jun 13, 1980	Original applicationNew combination · Standard review	Approved	None posted

Products

3 strengths and forms

Product	Active ingredient	Marketing
Minizide0.5MG;EQ 1MG BASE · capsule;oral	Polythiazide; Prazosin Hydrochloride	Discontinued
Minizide0.5MG;EQ 2MG BASE · capsule;oral	Polythiazide; Prazosin Hydrochloride	Discontinued
Minizide0.5MG;EQ 5MG BASE · capsule;oral	Polythiazide; Prazosin Hydrochloride	Discontinued

All 13 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 10, 1994	Supplement 12Manufacturing · Standard review	Approved	None posted
Jun 26, 1992	Supplement 11Manufacturing · Standard review	Approved	None posted
May 1, 1989	Supplement 10Labeling	Approved	None posted
Feb 26, 1985	Supplement 9Labeling	Approved	None posted
Aug 22, 1984	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 13, 1984	Supplement 8Labeling	Approved	None posted
Aug 1, 1984	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 6, 1984	Supplement 7Manufacturing · Standard review	Approved	None posted
Jul 2, 1982	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 1, 1981	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 31, 1981	Supplement 3Manufacturing · Standard review	Approved	None posted
Feb 19, 1981	Supplement 1Labeling	Approved	None posted
Jun 13, 1980	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 17986
Drugs@FDA: Overview at FDA
Company: Pfizer

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