NDA 061015

CASPER PHARMA LLC

FDA Drug Application

Application #061015

Application Sponsors

NDA 061015

CASPER PHARMA LLC

Marketing Status

• Discontinued: 001

Application Products

001

OINTMENT;OPHTHALMIC

EQ 5MG BASE/GM;10,000 UNITS/GM

0

TERRAMYCIN W/ POLYMYXIN B SULFATE

OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATE

FDA Submissions

	ORIG	1	AP	1965-07-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1998-02-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1999-04-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1999-04-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-03-22
LABELING; Labeling	SUPPL	6	AP	2004-10-25

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0

CDER Filings

CASPER PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 61015
            [companyName] => CASPER PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TERRAMYCIN W\/ POLYMYXIN B SULFATE","activeIngredients":"OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATE","strength":"EQ 5MG BASE\/GM;10,000 UNITS\/GM","dosageForm":"OINTMENT;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TERRAMYCIN W\/ POLYMYXIN B SULFATE","submission":"OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATE","actionType":"EQ 5MG BASE\/GM;10,000 UNITS\/GM","submissionClassification":"OINTMENT;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)