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Last Updated: October 28, 2021

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Details for New Drug Application (NDA): 208635

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NDA 208635 describes SODIUM NITROPRUSSIDE, which is a drug marketed by Abraxis Pharm, Akorn, Amneal, Amphastar Pharms Inc, Aurobindo Pharma Ltd, Baxter Hlthcare, Be Pharms, Cipla, Dr Reddys Labs Ltd, Hainan Poly Pharm, Hong Kong, Medicure, Micro Labs, Mylan Labs Ltd, Nexus Pharms, Sagent Pharms Inc, Somerset Theraps Llc, Sun Pharm, Teva Parenteral, Virtus Pharm, and Xiromed, and is included in twenty-one 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 are one thousand four hundred and seventy-two drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the sodium nitroprusside profile page.
Summary for 208635
Ingredient:sodium nitroprusside
Formulation / Manufacturing:see details
Pharmacology for NDA: 208635
Physiological EffectVasodilation
Suppliers and Packaging for NDA: 208635
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM NITROPRUSSIDE sodium nitroprusside INJECTABLE;INJECTION 208635 ANDA Akorn, Inc. 17478-014 17478-014-02 1 VIAL, SINGLE-DOSE in 1 CARTON (17478-014-02) > 2 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength25MG/ML
Approval Date:May 4, 2017TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Express Scripts

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