APPLICATION
NDA017741
TYPE
NDA
ORIGINAL APPROVAL
1977-09-14
LATEST ACTION
2017-10-25
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued
Products
FLORONEDiscontinued
DIFLORASONE DIACETATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CREAM · TOPICAL
Approval history
1997-10-10Manufacturing (CMC) · Supplement 19 · standardAP
1996-05-17Manufacturing (CMC) · Supplement 18 · standardAP
1989-05-30Manufacturing (CMC) · Supplement 17 · standardAP
1988-03-02Manufacturing (CMC) · Supplement 16 · standardAP
1984-03-29Labeling · Supplement 14AP
1982-08-20Labeling · Supplement 12AP
1982-08-20Labeling · Supplement 13AP
1981-10-21Labeling · Supplement 11AP
1981-05-05Manufacturing (CMC) · Supplement 10 · standardAP
1981-02-18Labeling · Supplement 8AP
1981-02-18Labeling · Supplement 7AP
1981-02-04Labeling · Supplement 1AP
1981-01-16Manufacturing (CMC) · Supplement 6 · standardAP
1979-10-24Manufacturing (CMC) · Supplement 4 · standardAP
1979-07-16Labeling · Supplement 3AP
1979-05-22Manufacturing (CMC) · Supplement 5 · standardAP
1978-11-07Labeling · Supplement 2AP
1977-09-14Type 1 - New Molecular Entity · 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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