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FDA NDA · NDA202067

ONFI

clobazam

Sponsor: LUNDBECK PHARMS LLC

APPLICATION
NDA202067
TYPE
NDA
ORIGINAL APPROVAL
2011-10-21
LATEST ACTION
2024-03-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

ONFI · ReferencePrescription
CLOBAZAM 20MG · TABLET · ORAL
ONFI · ReferenceDiscontinued
CLOBAZAM 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ONFI · ReferencePrescription
CLOBAZAM 10MG · TABLET · ORAL

Approval history

2024-03-12Labeling · Supplement 8 · standard — Label ↗AP
2023-01-13Labeling · Supplement 7 · standard — Letter ↗AP
2021-02-05Labeling · Supplement 6 · standard — Letter ↗AP
2018-06-15Labeling · Supplement 5 · standard — Letter ↗AP
2016-12-16Labeling · Supplement 4 · standard — Label ↗AP
2014-12-09Labeling · Supplement 3 · standard — Label ↗AP
2013-11-21Labeling · Supplement 2 · standard — Label ↗AP
2013-03-01Manufacturing (CMC) · Supplement 1 · standard — Label ↗AP
2011-10-21Type 1 - New Molecular Entity · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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