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Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209387


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NDA 209387 describes NIPRIDE RTU IN SODIUM CHLORIDE 0.9%, which is a drug marketed by Exela Pharma Scs Llc and is included in one NDA. It is available from one supplier. Additional details are available on the NIPRIDE RTU IN SODIUM CHLORIDE 0.9% profile page.

The generic ingredient in NIPRIDE RTU IN SODIUM CHLORIDE 0.9% is sodium nitroprusside. There are one thousand four hundred and seventy-two drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the sodium nitroprusside profile page.
Summary for 209387
Tradename:NIPRIDE RTU IN SODIUM CHLORIDE 0.9%
Applicant:Exela Pharma Scs Llc
Ingredient:sodium nitroprusside
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 209387
Physiological EffectVasodilation
Suppliers and Packaging for NDA: 209387
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIPRIDE RTU IN SODIUM CHLORIDE 0.9% sodium nitroprusside SOLUTION;INTRAVENOUS 209387 NDA EXELA PHARMA SCIENCES, LLC 51754-1006 51754-1006-1 1 VIAL in 1 VIAL (51754-1006-1) > 100 mL in 1 VIAL
NIPRIDE RTU IN SODIUM CHLORIDE 0.9% sodium nitroprusside SOLUTION;INTRAVENOUS 209387 NDA EXELA PHARMA SCIENCES, LLC 51754-1029 51754-1029-1 1 VIAL in 1 CARTON (51754-1029-1) > 100 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength50MG/100ML (0.5MG/ML)
Approval Date:Mar 8, 2017TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrength10MG/50ML (0.2MG/ML)
Approval Date:Dec 7, 2017TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength20MG/100ML (0.2MG/ML)
Approval Date:Jul 13, 2018TE:RLD:Yes

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