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Last Updated: February 19, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210882

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NDA 210882 describes SODIUM NITROPRUSSIDE, which is a drug marketed by Abraxis Pharm, Akorn, Amneal, Amphastar Pharms Inc, Baxter Hlthcare, Caplin, Cipla, Dr Reddys Labs Ltd, Medicure, Micro Labs, Mylan Labs Ltd, Nexus Pharms, Sagent Pharms Inc, Somerset Theraps Llc, Sun Pharm, Teva Parenteral, and Virtus Pharm, and is included in seventeen NDAs. It is available from thirteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the sodium nitroprusside profile page.
Summary for 210882
Applicant:Somerset Theraps Llc
Ingredient:sodium nitroprusside
Formulation / Manufacturing:see details
Pharmacology for NDA: 210882
Physiological EffectVasodilation
Suppliers and Packaging for NDA: 210882
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM NITROPRUSSIDE sodium nitroprusside INJECTABLE;INJECTION 210882 ANDA Somerset Therapeutics, LLC 70069-261 70069-261-01 1 VIAL in 1 CARTON (70069-261-01) > 2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength25MG/ML
Approval Date:Aug 17, 2018TE:APRLD:No

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