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FDA NDA · NDA018907

METRONIDAZOLE

Sponsor: HIKMA

APPLICATION
NDA018907
TYPE
NDA
ORIGINAL APPROVAL
1984-03-30
LATEST ACTION
2025-01-06
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

METRONIDAZOLEDiscontinued
METRONIDAZOLE 500MG/100ML · INJECTABLE · INJECTION

Approval history

2025-01-06Labeling · Supplement 9 · standard — Letter ↗AP
2024-07-08Labeling · Supplement 8 · standard — Letter ↗AP
2021-12-15Labeling · Supplement 7 · standard — Label ↗AP
2021-03-05Labeling · Supplement 6 · standard — Letter ↗AP
1993-03-26Manufacturing (CMC) · Supplement 5AP
1988-12-20Labeling · Supplement 4AP
1988-12-08Manufacturing (CMC) · Supplement 3AP
1986-11-03Manufacturing (CMC) · Supplement 1AP
1984-03-30OriginalAP
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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