Metronidazole

NDA 18740, held by Fosun Pharma. Metronidazole.

As of Nov 14, 2026, NDA 18740 (Metronidazole), held by Fosun Pharma, was first approved by FDA on Oct 22, 1982, with 22 approved supplements and 0 published complete response letters.

First approved: Oct 22, 1982
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Oct 22, 1982	Original application	Approved	None posted

Products

2 strengths and forms


Metronidazole250MG · tablet;oral	Metronidazole	Discontinued
Metronidazole500MG · tablet;oral	Metronidazole	Discontinued

All 23 submissions, including labeling and manufacturing supplements


Jul 8, 2024	Supplement 42Labeling · Standard review	Approved	Letter Label
Dec 15, 2021	Supplement 41Labeling · Standard review	Approved	Letter Label
Mar 5, 2021	Supplement 40Labeling · Standard review	Approved	Letter Label
Apr 27, 2020	Supplement 39Labeling · Standard review	Approved	Letter Label
May 9, 2001	Supplement 36Manufacturing	Approved	None posted
Jul 21, 1998	Supplement 35Labeling	Approved	None posted
Aug 11, 1997	Supplement 34Manufacturing	Approved	None posted
May 5, 1997	Supplement 33Manufacturing	Approved	None posted
Nov 21, 1995	Supplement 32Manufacturing	Approved	None posted
Mar 13, 1995	Supplement 31Manufacturing	Approved	None posted
Aug 19, 1993	Supplement 30Manufacturing	Approved	None posted
Aug 19, 1993	Supplement 29Labeling	Approved	None posted
May 10, 1993	Supplement 28Labeling	Approved	None posted
Feb 22, 1991	Supplement 27Labeling	Approved	None posted
May 17, 1989	Supplement 26Labeling	Approved	None posted
Jan 28, 1988	Supplement 24Manufacturing	Approved	None posted
Jan 28, 1988	Supplement 23Manufacturing	Approved	None posted
Jan 28, 1988	Supplement 22Manufacturing	Approved	None posted
Jan 28, 1988	Supplement 20Manufacturing	Approved	None posted
Jan 28, 1988	Supplement 19Manufacturing	Approved	None posted
Jan 28, 1988	Supplement 18Manufacturing	Approved	None posted
May 9, 1986	Supplement 15Manufacturing	Approved	None posted
Oct 22, 1982	Original application	Approved	None posted

Identifiers

Application: NDA 18740
Drugs@FDA: Overview at FDA
Company: Fosun Pharma

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