Details for New Drug Application (NDA): 209387

NDA 209387 describes NIPRIDE RTU IN SODIUM CHLORIDE 0.9%, which is a drug marketed by Exela Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the NIPRIDE RTU IN SODIUM CHLORIDE 0.9% profile page.

The generic ingredient in NIPRIDE RTU IN SODIUM CHLORIDE 0.9% is sodium nitroprusside. There are one thousand four hundred and seventy-two drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the sodium nitroprusside profile page.

Summary for 209387

Tradename:	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%
Applicant:	Exela Pharma
Ingredient:	sodium nitroprusside
Patents:	0

Pharmacology for NDA: 209387

Physiological Effect

Vasodilation

Suppliers and Packaging for NDA: 209387

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	sodium nitroprusside	SOLUTION;INTRAVENOUS	209387	NDA	EXELA PHARMA SCIENCES, LLC	51754-1006	51754-1006-1	1 VIAL in 1 VIAL (51754-1006-1) / 100 mL in 1 VIAL
NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	sodium nitroprusside	SOLUTION;INTRAVENOUS	209387	NDA	EXELA PHARMA SCIENCES, LLC	51754-1029	51754-1029-1	1 VIAL in 1 CARTON (51754-1029-1) / 100 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	50MG/100ML (0.5MG/ML)
Approval Date:	Mar 8, 2017	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	10MG/50ML (0.2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Dec 7, 2017	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	20MG/100ML (0.2MG/ML)
Approval Date:	Jul 13, 2018	TE:	AP	RLD:	Yes

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