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FDA NDA · NDA209570

BENZNIDAZOLE

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APPLICATION
NDA209570
TYPE
NDA
ORIGINAL APPROVAL
2017-08-29
LATEST ACTION
2021-12-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

BENZNIDAZOLE · ReferencePrescription
BENZNIDAZOLE 100MG · TABLET · ORAL
BENZNIDAZOLE · ReferencePrescription
BENZNIDAZOLE 12.5MG · TABLET · ORAL

Approval history

2021-12-15Labeling · Supplement 2 · standard — Label ↗AP
2019-11-07Labeling · Supplement 1 · standard — Letter ↗AP
2017-08-29Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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