FDA NDA · NDA021055

TARGRETIN

bexarotene

Sponsor: BAUSCH

APPLICATION

NDA021055

TYPE

NDA

ORIGINAL APPROVAL

1999-12-29

LATEST ACTION

2015-09-14

ROUTE

ORAL

DOSAGE FORM

CAPSULE

MARKETING STATUS

Prescription

Products

TARGRETIN · ReferencePrescription

BEXAROTENE 75MG · CAPSULE · ORAL

2015-09-14Manufacturing (CMC) · Supplement 11 · priorityAP

2015-07-29Efficacy · Supplement 10 · standard — Label ↗AP

2014-12-02Manufacturing (CMC) · Supplement 9 · priorityAP

2012-01-06Labeling · Supplement 8 · standard — Label ↗AP

2011-05-16Labeling · Supplement 6 · standard — Label ↗AP

2003-04-21Labeling · Supplement 2 · standard — Letter ↗AP

2003-04-21Labeling · Supplement 3 · standard — Letter ↗AP

2002-01-29Manufacturing (CMC) · Supplement 4 · priorityAP

2001-02-14Manufacturing (CMC) · Supplement 1 · priorityAP

1999-12-29Type 1 - New Molecular Entity · Original · priority — Label ↗AP

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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