APPLICATION
NDA017522
TYPE
NDA
ORIGINAL APPROVAL
1974-07-19
LATEST ACTION
2016-05-13
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
RETIN-A · ReferencePrescription
TRETINOIN 0.05% · CREAM · TOPICAL
Approval history
2016-05-13Manufacturing (CMC) · Supplement 38 · standardAP
2013-01-08Manufacturing (CMC) · Supplement 36 · standardAP
2002-12-06Manufacturing (CMC) · Supplement 28 · standardAP
2001-03-20Manufacturing (CMC) · Supplement 27 · standardAP
1999-01-25Manufacturing (CMC) · Supplement 25 · standardAP
1998-07-23Manufacturing (CMC) · Supplement 24 · standardAP
1992-01-24Manufacturing (CMC) · Supplement 20 · standardAP
1990-08-28Labeling · Supplement 18AP
1990-08-28Labeling · Supplement 17AP
1990-07-03Manufacturing (CMC) · Supplement 19 · standardAP
1989-12-01Manufacturing (CMC) · Supplement 16 · standardAP
1986-08-26Manufacturing (CMC) · Supplement 14 · standardAP
1986-07-23Manufacturing (CMC) · Supplement 12 · standardAP
1985-06-17Manufacturing (CMC) · Supplement 13 · standardAP
1984-04-02Manufacturing (CMC) · Supplement 11 · standardAP
1983-06-06Manufacturing (CMC) · Supplement 10 · standardAP
1982-12-03Labeling · Supplement 8AP
1981-07-29Manufacturing (CMC) · Supplement 9 · standardAP
1980-04-28Labeling · Supplement 7AP
1978-12-01Labeling · Supplement 5AP
1978-04-19Manufacturing (CMC) · Supplement 4 · standardAP
1977-01-04Labeling · Supplement 3AP
1976-06-29Manufacturing (CMC) · Supplement 2 · standardAP
1974-10-24Manufacturing (CMC) · Supplement 1 · standardAP
1974-07-19Type 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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