APPLICATION
NDA017579
TYPE
NDA
ORIGINAL APPROVAL
1975-04-18
LATEST ACTION
2013-05-14
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription
Products
RETIN-A · ReferencePrescription
TRETINOIN 0.025% · GEL · TOPICAL
Approval history
2013-05-14Manufacturing (CMC) · Supplement 32 · standardAP
2001-03-20Manufacturing (CMC) · Supplement 24 · standardAP
1999-01-25Manufacturing (CMC) · Supplement 22 · standardAP
1998-07-23Manufacturing (CMC) · Supplement 21 · standardAP
1992-01-31Manufacturing (CMC) · Supplement 16 · standardAP
1990-08-28Labeling · Supplement 14AP
1990-08-28Labeling · Supplement 13AP
1990-07-03Manufacturing (CMC) · Supplement 15 · standardAP
1989-12-01Manufacturing (CMC) · Supplement 12 · standardAP
1986-07-23Manufacturing (CMC) · Supplement 9 · standardAP
1985-06-11Manufacturing (CMC) · Supplement 10 · standardAP
1982-11-30Labeling · Supplement 8AP
1981-07-29Manufacturing (CMC) · Supplement 7 · standardAP
1980-04-28Labeling · Supplement 5AP
1979-10-23Manufacturing (CMC) · Supplement 4 · standardAP
1978-12-01Labeling · Supplement 3AP
1977-06-14Manufacturing (CMC) · Supplement 2 · standardAP
1977-01-04Labeling · Supplement 1AP
1975-04-18Type 3 - New Dosage Form · 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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