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FDA ANDA · ANDA075529

TRETINOIN

Sponsor: PADAGIS US

APPLICATION
ANDA075529
TYPE
ANDA
ORIGINAL APPROVAL
2000-02-22
LATEST ACTION
2007-04-20
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

TRETINOINPrescription
TRETINOIN 0.025% · GEL · TOPICAL

Approval history

2007-04-20Labeling · Supplement 10AP
2007-02-21Labeling · Supplement 8AP
2002-07-11Manufacturing (CMC) · Supplement 4AP
2001-08-13Manufacturing (CMC) · Supplement 3AP
2001-02-26Manufacturing (CMC) · Supplement 2AP
2000-02-22OriginalReviewAP
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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