APPLICATION
ANDA075264
TYPE
ANDA
ORIGINAL APPROVAL
1998-12-24
LATEST ACTION
2007-04-20
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
TRETINOINPrescription
TRETINOIN 0.025% · CREAM · TOPICAL
Approval history
2007-04-20Labeling · Supplement 26AP
2007-02-21Labeling · Supplement 24AP
2001-10-24Manufacturing (CMC) · Supplement 15AP
2001-10-24Manufacturing (CMC) · Supplement 13AP
2001-10-24Manufacturing (CMC) · Supplement 14AP
2001-01-23Manufacturing (CMC) · Supplement 7AP
2001-01-23Manufacturing (CMC) · Supplement 12AP
2001-01-23Manufacturing (CMC) · Supplement 6AP
2000-08-01Manufacturing (CMC) · Supplement 9AP
2000-08-01Manufacturing (CMC) · Supplement 8AP
2000-02-29Manufacturing (CMC) · Supplement 5AP
1999-12-23Manufacturing (CMC) · Supplement 3AP
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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