APPLICATION
ANDA070039
TYPE
ANDA
ORIGINAL APPROVAL
1985-01-29
LATEST ACTION
2024-10-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METRONIDAZOLEDiscontinued
METRONIDAZOLE 500MG · TABLET · ORAL
Approval history
2024-10-15Labeling · Supplement 18 · standardAP
2024-07-08Labeling · Supplement 17 · standardAP
2024-01-05Labeling · Supplement 16 · standardAP
2022-03-31Labeling · Supplement 15 · standardAP
2021-08-19Labeling · Supplement 14 · standardAP
2019-07-29Labeling · Supplement 13 · standardAP
1992-04-16Labeling · Supplement 11AP
1988-11-01Bioequivalence · Supplement 8AP
1988-06-16Labeling · Supplement 6AP
1986-05-23Manufacturing (CMC) · Supplement 2AP
1986-05-23Manufacturing (CMC) · Supplement 3AP
1985-01-29OriginalAP
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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