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FDA NDA · NDA018677

CESAMET

nabilone

Sponsor: BAUSCH

APPLICATION
NDA018677
TYPE
NDA
ORIGINAL APPROVAL
1985-12-26
LATEST ACTION
2022-04-28
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

CESAMET · ReferenceDiscontinued
NABILONE 1MG · CAPSULE · ORAL

Approval history

2022-04-28Labeling · Supplement 17 · standard — Letter ↗AP
2015-03-30Manufacturing (CMC) · Supplement 15 · standardAP
2008-12-05Manufacturing (CMC) · Supplement 13 · standard — Letter ↗AP
2006-05-15Labeling · Supplement 11 · standard — Letter ↗AP
1989-06-23Labeling · Supplement 6AP
1989-04-11Labeling · Supplement 5AP
1988-03-18Labeling · Supplement 4AP
1987-11-30Labeling · Supplement 3AP
1986-12-04Manufacturing (CMC) · Supplement 1 · standardAP
1986-12-04Manufacturing (CMC) · Supplement 2 · standardAP
1985-12-26Type 1 - New Molecular Entity · Original · standard — Review ↗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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