Details for New Drug Application (NDA): 211016

NDA 211016 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 211016

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

Pharmacology for NDA: 211016

Physiological Effect

Vasodilation

Suppliers and Packaging for NDA: 211016

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SODIUM NITROPRUSSIDE	sodium nitroprusside	INJECTABLE;INJECTION	211016	ANDA	Caplin Steriles Limited	65145-101	65145-101-01	1 VIAL, SINGLE-DOSE in 1 CARTON (65145-101-01) / 2 mL in 1 VIAL, SINGLE-DOSE
SODIUM NITROPRUSSIDE	sodium nitroprusside	INJECTABLE;INJECTION	211016	ANDA	Meitheal Pharmaceuticals Inc.	71288-202	71288-202-02	1 VIAL, SINGLE-DOSE in 1 CARTON (71288-202-02) / 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:	Nov 29, 2019	TE:	AP	RLD:	No

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