NDA 209387

EXELA PHARMA SCS LLC

FDA Drug Application

Application #209387

Documents

• Label: 2017-03-09
• Letter: 2017-03-14
• Review: 2017-08-23
• Letter: 2018-05-24
• Label: 2018-05-25
• Label: 2021-07-07

Application Sponsors

NDA 209387

EXELA PHARMA SCS LLC

Marketing Status

• Prescription: 001
• Discontinued: 002
• Prescription: 003

Application Products

001	SOLUTION;INTRAVENOUS	50MG/100ML (0.5MG/ML)	1	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	SODIUM NITROPRUSSIDE
002	SOLUTION;INTRAVENOUS	10MG/50ML (0.2MG/ML)	1	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	SODIUM NITROPRUSSIDE
003	SOLUTION;INTRAVENOUS	20MG/100ML (0.2MG/ML)	1	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	SODIUM NITROPRUSSIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2017-03-08	STANDARD
LABELING; Labeling	SUPPL	3	AP	2018-05-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2018-07-13	N/A

Submissions Property Types

ORIG	1	Null	6
SUPPL	3	Null	7
SUPPL	4	Null	15

TE Codes

001	Prescription	AP
003	Prescription	AP

CDER Filings

EXELA PHARMA

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            [ApplNo] => 209387
            [companyName] => EXELA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"NIPRIDE RTU IN SODIUM CHLORIDE 0.9%","activeIngredients":"SODIUM NITROPRUSSIDE","strength":"50MG\/100ML (0.5MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"NIPRIDE RTU IN SODIUM CHLORIDE 0.9%","activeIngredients":"SODIUM NITROPRUSSIDE","strength":"10MG\/50ML (0.2MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"NIPRIDE RTU IN SODIUM CHLORIDE 0.9%","activeIngredients":"SODIUM NITROPRUSSIDE","strength":"20MG\/100ML (0.2MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
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            [originalApprovals] => [{"actionDate":"03\/08\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209387s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209387Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/209387Orig1s000TOC.cfm\"}]","notes":">"}]
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            [actionDate] => 2018-07-13
        )

)