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FDA NDA · NDA018930

METRONIDAZOLE

Sponsor: CHARTWELL MOLECULES

APPLICATION
NDA018930
TYPE
NDA
ORIGINAL APPROVAL
1983-08-18
LATEST ACTION
2024-07-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

METRONIDAZOLEDiscontinued
METRONIDAZOLE 500MG · TABLET · ORAL

Approval history

2024-07-08Labeling · Supplement 16 · standard — Label ↗AP
2021-12-15Labeling · Supplement 15 · standard — Label ↗AP
2021-03-05Labeling · Supplement 14 · standard — Letter ↗AP
2020-04-27Labeling · Supplement 13 · standard — Label ↗AP
1992-04-16Labeling · Supplement 12AP
1988-11-03Labeling · Supplement 11AP
1988-06-16Labeling · Supplement 10AP
1986-06-03Manufacturing (CMC) · Supplement 6AP
1986-06-03Manufacturing (CMC) · Supplement 7AP
1985-06-06Manufacturing (CMC) · Supplement 4AP
1985-04-08Manufacturing (CMC) · Supplement 5AP
1983-08-18OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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