APPLICATION
ANDA206191
TYPE
ANDA
ORIGINAL APPROVAL
2019-02-25
LATEST ACTION
2024-12-03
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
METRONIDAZOLE IN PLASTIC CONTAINERPrescription
METRONIDAZOLE 500MG/100ML · INJECTABLE · INJECTION
Approval history
2024-12-03Labeling · Supplement 16 · standardAP
2023-09-19Labeling · Supplement 12 · standardAP
2023-09-19Labeling · Supplement 5 · standardAP
2023-09-19Labeling · Supplement 6 · standardAP
2019-02-25UNKNOWN · 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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