APPLICATION
NDA018889
TYPE
NDA
ORIGINAL APPROVAL
1983-11-18
LATEST ACTION
1996-09-20
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
METRONIDAZOLEDiscontinued
METRONIDAZOLE 500MG/100ML · INJECTABLE · INJECTION
Approval history
1996-09-20Manufacturing (CMC) · Supplement 11AP
1993-06-23Labeling · Supplement 10AP
1989-11-20Labeling · Supplement 9AP
1989-08-17Labeling · Supplement 8AP
1985-04-03Manufacturing (CMC) · Supplement 4AP
1984-07-24Manufacturing (CMC) · Supplement 3AP
1983-11-18OriginalAP
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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