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FDA NDA · NDA010060

FLORINEF

Sponsor: CASPER PHARMA LLC

APPLICATION
NDA010060
TYPE
NDA
ORIGINAL APPROVAL
1955-08-18
LATEST ACTION
2004-06-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

FLORINEF · ReferenceDiscontinued
FLUDROCORTISONE ACETATE 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2004-06-29Labeling · Supplement 17 · standard — Letter ↗AP
1999-08-20Manufacturing (CMC) · Supplement 16 · standardAP
1995-03-24Labeling · Supplement 15 · standardAP
1994-10-11Manufacturing (CMC) · Supplement 14 · standardAP
1993-03-31Labeling · Supplement 13AP
1988-05-09Labeling · Supplement 12AP
1982-11-18Labeling · Supplement 10AP
1979-01-22Manufacturing (CMC) · Supplement 9 · standardAP
1955-08-18Type 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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