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Generated: January 16, 2019

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Details for New Drug Application (NDA): 071961

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NDA 071961 describes NITROPRESS, which is a drug marketed by Abbott, Abbvie, and Hospira, and is included in four NDAs. It is available from one supplier. Additional details are available on the NITROPRESS profile page.

The generic ingredient in NITROPRESS is sodium nitroprusside. There are one thousand four hundred and fifty-four drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the sodium nitroprusside profile page.
Summary for 071961
Ingredient:sodium nitroprusside
Formulation / Manufacturing:see details
Pharmacology for NDA: 071961
Physiological EffectVasodilation
Suppliers and Packaging for NDA: 071961
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITROPRESS sodium nitroprusside INJECTABLE;INJECTION 071961 ANDA Valeant Pharmaceuticals North America LLC 0187-4302 0187-4302-02 1 VIAL in 1 CARTON (0187-4302-02) > 2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength25MG/ML
Approval Date:Aug 1, 1988TE:APRLD:No

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