NDA 050417

CASPER PHARMA LLC

FDA Drug Application

Application #050417

Documents

• Letter: 2004-05-04
• Label: 2004-05-04
• Label: 2020-05-22
• Letter: 2020-05-28

Application Sponsors

NDA 050417

CASPER PHARMA LLC

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT;OPHTHALMIC

400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM

1

NEOSPORIN

BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	1971-05-10	UNKNOWN
LABELING; Labeling	SUPPL	4	AP	1994-05-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1992-08-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1993-03-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1993-09-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1995-02-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1999-02-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1999-04-19
LABELING; Labeling	SUPPL	11	AP	2004-04-30	STANDARD
LABELING; Labeling	SUPPL	12	AP	2020-05-21	STANDARD

Submissions Property Types

SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	9
SUPPL	12	Null	7

TE Codes

001

Prescription

AT

CDER Filings

CASPER PHARMA LLC

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(
    [0] => Array
        (
            [ApplNo] => 50417
            [companyName] => CASPER PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LUMI-SPORYN","activeIngredients":"BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","strength":"EQ 400 UNITS\/GM;EQ 3.5MG BASE\/GM;EQ 10,000 UNITS\/GM","dosageForm":"OINTMENT;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"05\/21\/2020","submission":"SUPPL-12","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/050417s012lbl.pdf\"}]","notes":""},{"actionDate":"05\/21\/2020","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/050417s012lbl.pdf\"}]","notes":""},{"actionDate":"04\/30\/2004","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/50417slr011_neosporin_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LUMI-SPORYN","submission":"BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","actionType":"EQ 400 UNITS\/GM;EQ 3.5MG BASE\/GM;EQ 10,000 UNITS\/GM","submissionClassification":"OINTMENT;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-05-21
        )

)