Details for New Drug Application (NDA): 214199

NDA 214199 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, Hainan Poly, Micro Labs, Mylan Labs Ltd, Nexus, Pharmobedient, Sagent Pharms Inc, 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 is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the sodium nitroprusside profile page.

Summary for 214199

Tradename:	SODIUM NITROPRUSSIDE
Applicant:	Hainan Poly
Ingredient:	sodium nitroprusside
Patents:	0

Pharmacology for NDA: 214199

Physiological Effect

Vasodilation

Suppliers and Packaging for NDA: 214199

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SODIUM NITROPRUSSIDE	sodium nitroprusside	INJECTABLE;INJECTION	214199	ANDA	Hainan Poly Pharm. Co., Ltd.	14335-131	14335-131-01	1 VIAL in 1 CARTON (14335-131-01) / 2 mL in 1 VIAL
SODIUM NITROPRUSSIDE	sodium nitroprusside	INJECTABLE;INJECTION	214199	ANDA	Slate Run Pharmaceuticals, LLC	70436-028	70436-028-80	1 VIAL in 1 CARTON (70436-028-80) / 2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	25MG/ML
Approval Date:	Aug 25, 2020	TE:	AP	RLD:	No

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