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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 207499


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NDA 207499 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 207499
Tradename:SODIUM NITROPRUSSIDE
Applicant:Nexus
Ingredient:sodium nitroprusside
Patents:0
Pharmacology for NDA: 207499
Physiological EffectVasodilation
Suppliers and Packaging for NDA: 207499
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM NITROPRUSSIDE sodium nitroprusside INJECTABLE;INJECTION 207499 ANDA Nexus Pharmaceuticals LLC 14789-012 14789-012-02 1 VIAL, GLASS in 1 CARTON (14789-012-02) / 2 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength25MG/ML
Approval Date:May 25, 2017TE:APRLD:No

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