APPLICATION
NDA018353
TYPE
NDA
ORIGINAL APPROVAL
1980-11-28
LATEST ACTION
2015-07-13
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
FLAGYL I.V. RTU IN PLASTIC CONTAINERDiscontinued
METRONIDAZOLE 500MG/100ML · INJECTABLE · INJECTION
FLAGYL I.V.Discontinued
METRONIDAZOLE HYDROCHLORIDE EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
1993-03-05Manufacturing (CMC) · Supplement 25 · priorityAP
1992-11-30Labeling · Supplement 24AP
1989-04-13Labeling · Supplement 23AP
1988-02-17Labeling · Supplement 16AP
1988-02-17Labeling · Supplement 22AP
1988-02-17Labeling · Supplement 14AP
1988-02-17Efficacy · Supplement 15AP
1987-10-29Manufacturing (CMC) · Supplement 13 · priorityAP
1987-08-21Manufacturing (CMC) · Supplement 11 · priorityAP
1986-09-09Manufacturing (CMC) · Supplement 21 · priorityAP
1986-09-02Labeling · Supplement 20AP
1986-06-20Manufacturing (CMC) · Supplement 17 · priorityAP
1986-04-24Manufacturing (CMC) · Supplement 18 · priorityAP
1984-12-20Labeling · Supplement 2AP
1983-12-14Labeling · Supplement 10AP
1982-12-02Manufacturing (CMC) · Supplement 9 · priorityAP
1982-09-15Manufacturing (CMC) · Supplement 8 · priorityAP
1982-06-30Labeling · Supplement 7AP
1982-01-11Manufacturing (CMC) · Supplement 6 · priorityAP
1981-11-25Manufacturing (CMC) · Supplement 3 · priorityAP
1981-11-02Manufacturing (CMC) · Supplement 5 · priorityAP
1981-05-29Manufacturing (CMC) · Supplement 1 · priorityAP
1980-11-28Type 3 - New Dosage Form · Original · priorityAP
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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