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FDA ANDA · ANDA208681

METRONIDAZOLE

Sponsor: ALEMBIC

APPLICATION
ANDA208681
TYPE
ANDA
ORIGINAL APPROVAL
2017-06-20
LATEST ACTION
2024-11-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

METRONIDAZOLEPrescription
METRONIDAZOLE 250MG · TABLET · ORAL
METRONIDAZOLEPrescription
METRONIDAZOLE 500MG · TABLET · ORAL

Approval history

2024-11-05Labeling · Supplement 2 · standardAP
2024-07-08Labeling · Supplement 1 · standardAP
2017-06-20UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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