APPLICATION
NDA020404
TYPE
NDA
ORIGINAL APPROVAL
1997-01-14
LATEST ACTION
2002-01-22
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
AVITAPrescription
TRETINOIN 0.025% · CREAM · TOPICAL
Approval history
2002-01-22Manufacturing (CMC) · Supplement 5 · standardAP
2001-04-30Manufacturing (CMC) · Supplement 4 · standardAP
2000-03-31Manufacturing (CMC) · Supplement 3 · standardAP
1999-12-15Manufacturing (CMC) · Supplement 2 · standardAP
1997-01-14Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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