APPLICATION
ANDA208162
TYPE
ANDA
ORIGINAL APPROVAL
2016-05-25
LATEST ACTION
2024-11-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METRONIDAZOLEPrescription
METRONIDAZOLE 500MG · TABLET · ORAL
METRONIDAZOLEPrescription
METRONIDAZOLE 250MG · TABLET · ORAL
Approval history
2024-11-05Labeling · Supplement 12 · standardAP
2024-07-08Labeling · Supplement 11 · standardAP
2024-01-09Labeling · Supplement 9 · standardAP
2024-01-09Labeling · Supplement 10 · standardAP
2021-08-19Labeling · Supplement 8 · standardAP
2019-07-30Labeling · Supplement 6 · standardAP
2016-05-25UNKNOWN · Original · standardAP
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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