FDA NDA · NDA020600

TAZORAC

tazarotene

Sponsor: ALMIRALL

APPLICATION

NDA020600

TYPE

NDA

ORIGINAL APPROVAL

1997-06-13

LATEST ACTION

2018-04-16

ROUTE

CUTANEOUS, TOPICAL

DOSAGE FORM

GEL

MARKETING STATUS

Prescription

Products

TAZORAC · ReferencePrescription

TAZAROTENE 0.05% · GEL · TOPICAL

TAZORAC · ReferencePrescription

TAZAROTENE 0.1% · GEL · TOPICAL

2018-04-16Labeling · Supplement 10 · standard — Label ↗AP

2017-07-21Labeling · Supplement 9 · standard — Label ↗AP

2011-02-25Labeling · Supplement 8 · standard — Label ↗AP

2003-12-02Labeling · Supplement 5 · standard — Letter ↗AP

2003-12-02Labeling · Supplement 3 · standard — Letter ↗AP

1999-06-17Manufacturing (CMC) · Supplement 1 · standardAP

1999-06-17Manufacturing (CMC) · Supplement 2 · standardAP

1997-06-13Type 1 - New Molecular Entity · Original · standard — Review ↗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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