Metrogel

NDA 19737, held by Galderma Labs LP. Metronidazole.

As of Nov 13, 2026, NDA 19737 (Metrogel), held by Galderma Labs LP, was first approved by FDA on Nov 22, 1988, with 7 approved supplements and 0 published complete response letters.

First approved: Nov 22, 1988
Review: Priority
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Nov 22, 1988	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Metrogel0.75% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · gel;topical	Metronidazole	DiscontinuedReference drug

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 4, 2002	Supplement 7Manufacturing · Priority review	Approved	Letter
Aug 21, 1995	Supplement 6Labeling · Standard review	Approved	None posted
Mar 24, 1994	Supplement 5Manufacturing · Priority review	Approved	None posted
May 15, 1990	Supplement 4Manufacturing · Priority review	Approved	None posted
Jun 20, 1989	Supplement 3Manufacturing · Priority review	Approved	None posted
Jan 19, 1989	Supplement 2Manufacturing · Priority review	Approved	None posted
Dec 2, 1988	Supplement 1Manufacturing · Priority review	Approved	None posted
Nov 22, 1988	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 19737
Drugs@FDA: Overview at FDA
Company: Galderma Laboratories

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