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FDA NDA · NDA210833

SYMPAZAN

clobazam

Sponsor: COSETTE

APPLICATION
NDA210833
TYPE
NDA
ORIGINAL APPROVAL
2018-11-01
LATEST ACTION
2024-03-12
ROUTE
ORAL
DOSAGE FORM
FILM
MARKETING STATUS
Prescription

Products

SYMPAZAN · ReferencePrescription
CLOBAZAM 20MG · FILM · ORAL
SYMPAZAN · ReferencePrescription
CLOBAZAM 5MG · FILM · ORAL
SYMPAZAN · ReferencePrescription
CLOBAZAM 10MG · FILM · ORAL

Approval history

2024-03-12Labeling · Supplement 6 · standard — Label ↗AP
2023-01-13Labeling · Supplement 4 · standard — Letter ↗AP
2021-03-16Labeling · Supplement 2 · standard — Letter ↗AP
2021-02-05Labeling · Supplement 3 · standard — Letter ↗AP
2020-12-09Labeling · Supplement 1 · standard — Letter ↗AP
2018-11-01Type 3 - New Dosage Form · Original · standard — 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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