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FDA NDA · NDA013790

CORDRAN

Sponsor: INA PHARMS

APPLICATION
NDA013790
TYPE
NDA
ORIGINAL APPROVAL
1963-03-19
LATEST ACTION
2011-07-27
ROUTE
TOPICAL
DOSAGE FORM
LOTION
MARKETING STATUS
Discontinued

Products

CORDRAN · ReferenceDiscontinued
FLURANDRENOLIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · LOTION · TOPICAL

Approval history

2011-07-27Manufacturing (CMC) · Supplement 21 · standard — Letter ↗AP
2003-10-31Manufacturing (CMC) · Supplement 18 · standard — Letter ↗AP
2000-09-27Manufacturing (CMC) · Supplement 17 · standardAP
1998-11-06Manufacturing (CMC) · Supplement 16 · standardAP
1995-11-06Manufacturing (CMC) · Supplement 14 · standardAP
1987-12-18Manufacturing (CMC) · Supplement 13 · standardAP
1987-06-03Manufacturing (CMC) · Supplement 12 · standardAP
1987-06-03Manufacturing (CMC) · Supplement 11 · standardAP
1982-08-06Labeling · Supplement 10AP
1980-06-17Manufacturing (CMC) · Supplement 9 · standardAP
1978-09-12Labeling · Supplement 8AP
1977-02-23Labeling · Supplement 7AP
1963-03-19Type 3 - New Dosage Form · Original · standardAP
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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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