APPLICATION
ANDA209794
TYPE
ANDA
ORIGINAL APPROVAL
2017-12-12
LATEST ACTION
2024-07-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METRONIDAZOLEPrescription
METRONIDAZOLE 500MG · TABLET · ORAL
METRONIDAZOLEPrescription
METRONIDAZOLE 250MG · TABLET · ORAL
Approval history
2024-07-08Labeling · Supplement 6 · standardAP
2024-06-18Labeling · Supplement 4 · standardAP
2024-06-18Labeling · Supplement 2 · standardAP
2024-06-18Labeling · Supplement 5 · standardAP
2019-08-13Labeling · Supplement 1 · standardAP
2017-12-12UNKNOWN · 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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