← FDA DRUG APPROVALS

FDA NDA · NDA018764

METRONIDAZOLE

Sponsor: WATSON LABS

APPLICATION
NDA018764
TYPE
NDA
ORIGINAL APPROVAL
1982-09-17
LATEST ACTION
2021-12-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2021-12-15Labeling · Supplement 44 · standard — Label ↗AP
2021-03-05Labeling · Supplement 43 · standard — Letter ↗AP
2018-10-17Labeling · Supplement 42 · standard — Label ↗AP
2005-01-24Labeling · Supplement 31AP
2001-10-01Manufacturing (CMC) · Supplement 29AP
2001-04-25Manufacturing (CMC) · Supplement 28AP
1998-06-08Manufacturing (CMC) · Supplement 25AP
1997-08-08Labeling · Supplement 24AP
1991-08-22Labeling · Supplement 21AP
1991-08-07Manufacturing (CMC) · Supplement 19AP
1991-01-28Manufacturing (CMC) · Supplement 20AP
1988-07-22Labeling · Supplement 18AP
1985-06-05Manufacturing (CMC) · Supplement 7AP
1985-06-05Manufacturing (CMC) · Supplement 6AP
1982-09-17OriginalAP
VIEW ON DRUGS@FDA ↗

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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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