NDA 060613

CASPER PHARMA LLC

FDA Drug Application

Application #060613

Documents

• Label: 2017-12-21

Application Sponsors

NDA 060613

CASPER PHARMA LLC

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION/DROPS;OTIC

1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

1

CASPORYN HC

HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

FDA Submissions

	ORIG	1	AP	1975-05-25
LABELING; Labeling	SUPPL	4	AP	1988-02-04
LABELING; Labeling	SUPPL	5	AP	1993-03-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1995-02-14
LABELING; Labeling	SUPPL	8	AP	2000-08-10
LABELING; Labeling	SUPPL	9	AP	2000-08-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1999-07-23
LABELING; Labeling	SUPPL	13	AP	2017-12-19	STANDARD

Submissions Property Types

SUPPL	7	Null	0
SUPPL	10	Null	0
SUPPL	13	Null	7

TE Codes

001

Prescription

AT

CDER Filings

CASPER PHARMA LLC

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(
    [0] => Array
        (
            [ApplNo] => 60613
            [companyName] => CASPER PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CASPORYN HC","activeIngredients":"HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","strength":"1%;EQ 3.5MG BASE\/ML;10,000 UNITS\/ML","dosageForm":"SUSPENSION\/DROPS;OTIC","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/19\/2017","submission":"SUPPL-13","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/060613s013lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CASPORYN HC","submission":"HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","actionType":"1%;EQ 3.5MG BASE\/ML;10,000 UNITS\/ML","submissionClassification":"SUSPENSION\/DROPS;OTIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-12-19
        )

)