Details for New Drug Application (NDA): 209352

NDA 209352 describes SODIUM NITROPRUSSIDE, which is a drug marketed by Abraxis Pharm, Amneal, Amphastar Pharms Inc, Avet Lifesciences, Baxter Hlthcare, Be Pharms, Caplin, Chartwell Rx, Cipla, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Micro Labs, Mylan Labs Ltd, Nexus, Pharmobedient, Sagent Pharms Inc, Slate Run Pharma, Somerset Theraps Llc, Sun Pharm, Teva Parenteral, and Xiromed, and is included in twenty-three NDAs. It is available from twelve suppliers. Additional details are available on the SODIUM NITROPRUSSIDE profile page.

The generic ingredient in SODIUM NITROPRUSSIDE is sodium nitroprusside. There are one thousand four hundred and seventy-two drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the sodium nitroprusside profile page.

Summary for 209352

Tradename:	SODIUM NITROPRUSSIDE
Applicant:	Micro Labs
Ingredient:	sodium nitroprusside
Patents:	0

Pharmacology for NDA: 209352

Physiological Effect

Vasodilation

Suppliers and Packaging for NDA: 209352

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SODIUM NITROPRUSSIDE	sodium nitroprusside	INJECTABLE;INJECTION	209352	ANDA	Micro Labs Limited	42571-265	42571-265-75	1 VIAL, SINGLE-DOSE in 1 CARTON (42571-265-75) / 2 mL in 1 VIAL, SINGLE-DOSE
SODIUM NITROPRUSSIDE	sodium nitroprusside	INJECTABLE;INJECTION	209352	ANDA	Armas Pharmaceuticals Inc.	72485-105	72485-105-01	1 VIAL, SINGLE-DOSE in 1 CARTON (72485-105-01) / 2 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	25MG/ML
Approval Date:	Dec 8, 2017	TE:	AP	RLD:	No

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