Renoquid

NDA 17569, held by Glenwood. Sulfacytine.

As of Nov 14, 2026, NDA 17569 (Renoquid), held by Glenwood, was first approved by FDA on Sep 12, 1975, with 6 approved supplements and 0 published complete response letters.

First approved: Sep 12, 1975
Review: Priority
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Sep 12, 1975	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Renoquid250MG · tablet;oral	Sulfacytine	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Dec 16, 1986	Supplement 6Labeling · Priority review	Approved	None posted
Apr 9, 1981	Supplement 5Manufacturing · Priority review	Approved	None posted
Oct 23, 1979	Supplement 4Manufacturing · Priority review	Approved	None posted
Jul 5, 1978	Supplement 3Manufacturing · Priority review	Approved	None posted
Jan 12, 1978	Supplement 2Manufacturing · Priority review	Approved	None posted
Nov 22, 1976	Supplement 1Manufacturing · Priority review	Approved	None posted
Sep 12, 1975	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 17569
Drugs@FDA: Overview at FDA
Company: Glenwood, LLC

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