APPLICATION
NDA012806
TYPE
NDA
ORIGINAL APPROVAL
1965-10-18
LATEST ACTION
2013-07-23
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT, CREAM
MARKETING STATUS
Discontinued
Products
CORDRAN · ReferenceDiscontinued
FLURANDRENOLIDE 0.05% · OINTMENT · TOPICAL
CORDRAN · ReferenceDiscontinued
FLURANDRENOLIDE 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · OINTMENT · TOPICAL
CORDRAN SP · ReferenceDiscontinued
FLURANDRENOLIDE 0.05% · CREAM · TOPICAL
CORDRAN SP · ReferenceDiscontinued
FLURANDRENOLIDE 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CREAM · TOPICAL
Approval history
2012-12-14Manufacturing (CMC) · Supplement 35 · standardAP
2008-03-25Manufacturing (CMC) · Supplement 32AP
1998-11-06Manufacturing (CMC) · Supplement 27 · standardAP
1991-08-30Manufacturing (CMC) · Supplement 26 · standardAP
1990-10-02Manufacturing (CMC) · Supplement 25 · standardAP
1987-12-18Manufacturing (CMC) · Supplement 24 · standardAP
1987-06-03Manufacturing (CMC) · Supplement 23 · standardAP
1986-11-14Labeling · Supplement 22AP
1982-10-08Labeling · Supplement 21AP
1980-08-12Labeling · Supplement 20AP
1979-11-26Manufacturing (CMC) · Supplement 19 · standardAP
1978-07-24Labeling · Supplement 16AP
1978-06-30Labeling · Supplement 17AP
1977-12-14Manufacturing (CMC) · Supplement 15 · standardAP
1977-11-11Manufacturing (CMC) · Supplement 13 · standardAP
1977-02-23Labeling · Supplement 14AP
1965-10-18Type 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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