APPLICATION
ANDA090222
TYPE
ANDA
ORIGINAL APPROVAL
2010-05-05
LATEST ACTION
2024-10-25
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
METRONIDAZOLEDiscontinued
METRONIDAZOLE 750MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2024-10-25Labeling · Supplement 6 · standardAP
2024-07-08Labeling · Supplement 5 · standardAP
2024-06-18Labeling · Supplement 4 · standardAP
2021-12-15Labeling · Supplement 3 · standardAP
2021-06-22Labeling · Supplement 2 · standardAP
2021-03-05Labeling · Supplement 1 · standardAP
2010-05-05OriginalAP
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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