NDA 050416

CASPER PHARMA LLC

FDA Drug Application

Application #050416

Documents

• Letter: 2004-03-24
• Label: 2004-04-05

Application Sponsors

NDA 050416

CASPER PHARMA LLC

Marketing Status

• Discontinued: 002

Application Products

002

OINTMENT;OPHTHALMIC

400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

CORTISPORIN

BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	1971-05-10	UNKNOWN
LABELING; Labeling	SUPPL	6	AP	1994-05-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1992-08-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1993-03-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1993-09-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1994-12-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1995-02-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1995-06-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1998-06-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1999-04-19
LABELING; Labeling	SUPPL	15	AP	2004-03-22	STANDARD

Submissions Property Types

SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	9

CDER Filings

CASPER PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50416
            [companyName] => CASPER PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CORTISPORIN","activeIngredients":"BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","strength":"400 UNITS\/GM;1%;EQ 3.5MG BASE\/GM;10,000 UNITS\/GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"OINTMENT;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"03\/22\/2004","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/50416slr015_cortisporin_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CORTISPORIN","submission":"BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","actionType":"400 UNITS\/GM;1%;EQ 3.5MG BASE\/GM;10,000 UNITS\/GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"OINTMENT;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2004-03-22
        )

)