APPLICATION
NDA017340
TYPE
NDA
ORIGINAL APPROVAL
1973-01-26
LATEST ACTION
2016-05-13
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
RETIN-A · ReferencePrescription
TRETINOIN 0.1% · CREAM · TOPICAL
Approval history
2016-05-13Manufacturing (CMC) · Supplement 48 · standardAP
2015-12-17Manufacturing (CMC) · Supplement 47 · standardAP
2013-01-08Manufacturing (CMC) · Supplement 46 · standardAP
2002-12-06Manufacturing (CMC) · Supplement 38 · standardAP
2001-03-20Manufacturing (CMC) · Supplement 37 · standardAP
1999-01-25Manufacturing (CMC) · Supplement 35 · standardAP
1998-07-23Manufacturing (CMC) · Supplement 34 · standardAP
1992-01-24Manufacturing (CMC) · Supplement 30 · standardAP
1990-08-28Labeling · Supplement 28AP
1990-08-28Labeling · Supplement 27AP
1990-07-03Manufacturing (CMC) · Supplement 29 · standardAP
1989-12-01Manufacturing (CMC) · Supplement 26 · standardAP
1989-04-12Labeling · Supplement 25AP
1986-08-26Manufacturing (CMC) · Supplement 23 · standardAP
1986-07-24Manufacturing (CMC) · Supplement 21 · standardAP
1985-06-11Manufacturing (CMC) · Supplement 22 · standardAP
1984-03-30Manufacturing (CMC) · Supplement 20 · standardAP
1983-06-06Manufacturing (CMC) · Supplement 19 · standardAP
1982-12-13Labeling · Supplement 17AP
1981-07-28Manufacturing (CMC) · Supplement 18 · standardAP
1978-12-04Labeling · Supplement 15AP
1977-01-04Labeling · Supplement 14AP
1976-06-30Manufacturing (CMC) · Supplement 13 · standardAP
1974-08-27Manufacturing (CMC) · Supplement 10 · standardAP
1974-04-15Supplement · Supplement 9 · standardAP
1974-04-15Supplement · Supplement 7 · standardAP
1973-01-26Type 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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