Details for New Drug Application (NDA): 211277

NDA 211277 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, Norvium Bioscience, 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 fifteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the sodium nitroprusside profile page.

Summary for 211277

Tradename:	SODIUM NITROPRUSSIDE
Applicant:	Xiromed
Ingredient:	sodium nitroprusside
Patents:	0

Pharmacology for NDA: 211277

Physiological Effect

Vasodilation

Suppliers and Packaging for NDA: 211277

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SODIUM NITROPRUSSIDE	sodium nitroprusside	INJECTABLE;INJECTION	211277	ANDA	Xiromed, LLC.	70700-126	70700-126-92	1 VIAL, SINGLE-DOSE in 1 CARTON (70700-126-92) / 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:	Oct 29, 2020	TE:	AP	RLD:	No

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