← FDA DRUG APPROVALS

FDA NDA · NDA018620

METRONIDAZOLE

Sponsor: FOSUN PHARMA

APPLICATION
NDA018620
TYPE
NDA
ORIGINAL APPROVAL
1982-03-04
LATEST ACTION
2024-07-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2024-07-08Labeling · Supplement 24 · standard — Letter ↗AP
2021-12-15Labeling · Supplement 23 · standard — Label ↗AP
2021-03-05Labeling · Supplement 22 · standard — Letter ↗AP
2020-04-27Labeling · Supplement 21 · standard — Label ↗AP
1995-06-12Manufacturing (CMC) · Supplement 20AP
1994-10-17Manufacturing (CMC) · Supplement 16AP
1992-11-06Labeling · Supplement 19AP
1992-07-17Labeling · Supplement 18AP
1992-01-10Labeling · Supplement 17AP
1991-02-15Labeling · Supplement 15AP
1991-02-04Manufacturing (CMC) · Supplement 14AP
1989-10-27Labeling · Supplement 13AP
1988-11-29Labeling · Supplement 12AP
1985-12-20Manufacturing (CMC) · Supplement 10AP
1985-10-02Manufacturing (CMC) · Supplement 11AP
1982-03-04OriginalAP
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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