NDA 010060

CASPER PHARMA LLC

FDA Drug Application

Application #010060

Documents

• Letter: 2004-06-30

Application Sponsors

NDA 010060

CASPER PHARMA LLC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

FLORINEF

FLUDROCORTISONE ACETATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1955-08-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1979-01-22	STANDARD
LABELING; Labeling	SUPPL	10	AP	1982-11-18
LABELING; Labeling	SUPPL	12	AP	1988-05-09
LABELING; Labeling	SUPPL	13	AP	1993-03-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1994-10-11	STANDARD
LABELING; Labeling	SUPPL	15	AP	1995-03-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1999-08-20	STANDARD
LABELING; Labeling	SUPPL	17	AP	2004-06-29	STANDARD

Submissions Property Types

SUPPL	9	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0

CDER Filings

CASPER PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 10060
            [companyName] => CASPER PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLORINEF","activeIngredients":"FLUDROCORTISONE ACETATE","strength":"0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLORINEF","submission":"FLUDROCORTISONE ACETATE","actionType":"0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)