← FDA DRUG APPROVALS

FDA NDA · NDA018740

METRONIDAZOLE

Sponsor: FOSUN PHARMA

APPLICATION
NDA018740
TYPE
NDA
ORIGINAL APPROVAL
1982-10-22
LATEST ACTION
2024-07-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

METRONIDAZOLEDiscontinued
METRONIDAZOLE 500MG · TABLET · ORAL
METRONIDAZOLEDiscontinued
METRONIDAZOLE 250MG · TABLET · ORAL

Approval history

2024-07-08Labeling · Supplement 42 · standard — Letter ↗AP
2021-12-15Labeling · Supplement 41 · standard — Label ↗AP
2021-03-05Labeling · Supplement 40 · standard — Letter ↗AP
2020-04-27Labeling · Supplement 39 · standard — Label ↗AP
2001-05-09Manufacturing (CMC) · Supplement 36AP
1998-07-21Labeling · Supplement 35AP
1997-08-11Manufacturing (CMC) · Supplement 34AP
1997-05-05Manufacturing (CMC) · Supplement 33AP
1995-11-21Manufacturing (CMC) · Supplement 32AP
1995-03-13Manufacturing (CMC) · Supplement 31AP
1993-08-19Manufacturing (CMC) · Supplement 30AP
1993-08-19Labeling · Supplement 29AP
1993-05-10Labeling · Supplement 28AP
1991-02-22Labeling · Supplement 27AP
1989-05-17Labeling · Supplement 26AP
1988-01-28Manufacturing (CMC) · Supplement 23AP
1988-01-28Manufacturing (CMC) · Supplement 18AP
1988-01-28Manufacturing (CMC) · Supplement 24AP
1988-01-28Manufacturing (CMC) · Supplement 22AP
1988-01-28Manufacturing (CMC) · Supplement 20AP
1988-01-28Manufacturing (CMC) · Supplement 19AP
1986-05-09Manufacturing (CMC) · Supplement 15AP
1982-10-22OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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