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FDA NDA · NDA021056

TARGRETIN

bexarotene

Sponsor: BAUSCH

APPLICATION
NDA021056
TYPE
NDA
ORIGINAL APPROVAL
2000-06-28
LATEST ACTION
2015-02-09
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

TARGRETIN · ReferencePrescription
BEXAROTENE 1% · GEL · TOPICAL

Approval history

2015-02-09Manufacturing (CMC) · Supplement 6 · priorityAP
2013-07-22Manufacturing (CMC) · Supplement 5 · priorityAP
2011-04-08Labeling · Supplement 3 · standard — Letter ↗AP
2002-03-14Manufacturing (CMC) · Supplement 1 · priorityAP
2000-06-28Type 3 - New Dosage Form · Original · priority — Review ↗AP
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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