Renese

NDA 12845, held by Pfizer. Polythiazide.

As of Nov 13, 2026, NDA 12845 (Renese), held by Pfizer, was first approved by FDA on Sep 26, 1961, with 13 approved supplements and 0 published complete response letters.

First approved: Sep 26, 1961
Review: Standard
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Sep 26, 1961	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

3 strengths and forms

Product	Active ingredient	Marketing
Renese1MG · tablet;oral	Polythiazide	Discontinued
Renese2MG · tablet;oral	Polythiazide	Discontinued
Renese4MG · tablet;oral	Polythiazide	Discontinued

All 14 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 24, 1998	Supplement 26Labeling · Standard review	Approved	None posted
Jun 26, 1992	Supplement 25Manufacturing · Standard review	Approved	None posted
Mar 20, 1984	Supplement 24Manufacturing · Standard review	Approved	None posted
Feb 7, 1984	Supplement 23Manufacturing · Standard review	Approved	None posted
Feb 5, 1981	Supplement 21Manufacturing · Standard review	Approved	None posted
Apr 6, 1979	Supplement 20Manufacturing · Standard review	Approved	None posted
May 22, 1978	Supplement 19Manufacturing · Standard review	Approved	None posted
Oct 6, 1977	Supplement 18Manufacturing · Standard review	Approved	None posted
Sep 28, 1976	Supplement 16Manufacturing · Standard review	Approved	None posted
Sep 28, 1976	Supplement 17Labeling	Approved	None posted
Oct 28, 1975	Supplement 14Manufacturing · Standard review	Approved	None posted
Jun 5, 1975	Supplement 13Manufacturing · Standard review	Approved	None posted
May 7, 1975	Supplement 12Labeling	Approved	None posted
Sep 26, 1961	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 12845
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