APPLICATION
ANDA079065
TYPE
ANDA
ORIGINAL APPROVAL
2009-06-23
LATEST ACTION
2025-02-14
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
METRONIDAZOLEPrescription
METRONIDAZOLE 375MG · CAPSULE · ORAL
Approval history
2025-02-14Labeling · Supplement 22 · standardAP
2024-01-11Labeling · Supplement 16 · standardAP
2024-01-11Labeling · Supplement 17 · standardAP
2019-11-04Labeling · Supplement 8 · standardAP
2019-11-04Labeling · Supplement 10 · standardAP
2017-09-11Labeling · Supplement 2 · standardAP
2009-06-23OriginalAP
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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