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FDA NDA · NDA022070

TRETINOIN

Sponsor: DOW PHARM

APPLICATION
NDA022070
TYPE
NDA
ORIGINAL APPROVAL
2007-07-26
LATEST ACTION
2015-01-05
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

ATRALIN · ReferencePrescription
TRETINOIN 0.05% · GEL · TOPICAL

Approval history

2015-01-05Manufacturing (CMC) · Supplement 4 · standardAP
2014-08-29Labeling · Supplement 3 · standard — Label ↗AP
2008-03-06Manufacturing (CMC) · Supplement 1AP
2007-07-26Type 3 - New Dosage Form · Original · standard — Label ↗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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