APPLICATION
NDA017994
TYPE
NDA
ORIGINAL APPROVAL
1978-03-01
LATEST ACTION
2017-10-25
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued
Products
PSORCON EDiscontinued
DIFLORASONE DIACETATE 0.05% · OINTMENT · TOPICAL
Approval history
1999-01-21Manufacturing (CMC) · Supplement 21 · standardAP
1997-10-10Manufacturing (CMC) · Supplement 20 · standardAP
1988-05-03Manufacturing (CMC) · Supplement 19 · standardAP
1986-01-03Manufacturing (CMC) · Supplement 18 · standardAP
1984-05-31Manufacturing (CMC) · Supplement 17 · standardAP
1984-03-29Labeling · Supplement 16AP
1983-11-04Manufacturing (CMC) · Supplement 15 · standardAP
1982-08-20Labeling · Supplement 13AP
1982-08-20Labeling · Supplement 14AP
1981-06-25Labeling · Supplement 11AP
1981-05-05Manufacturing (CMC) · Supplement 12 · standardAP
1981-02-18Labeling · Supplement 9AP
1981-01-16Manufacturing (CMC) · Supplement 8 · standardAP
1979-12-17Manufacturing (CMC) · Supplement 3 · standardAP
1979-07-16Manufacturing (CMC) · Supplement 7 · standardAP
1979-07-16Manufacturing (CMC) · Supplement 5 · standardAP
1979-07-16Manufacturing (CMC) · Supplement 6 · standardAP
1979-05-22Manufacturing (CMC) · Supplement 4 · standardAP
1979-01-10Manufacturing (CMC) · Supplement 1 · standardAP
1978-11-07Labeling · Supplement 2AP
1978-03-01Type 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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