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Generated: November 17, 2018

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Details for New Drug Application (NDA): 019635

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NDA 019635 describes SODIUM CHLORIDE 5% IN PLASTIC CONTAINER, which is a drug marketed by B Braun and Baxter Hlthcare and is included in two NDAs. It is available from two suppliers. Additional details are available on the SODIUM CHLORIDE 5% IN PLASTIC CONTAINER profile page.

The generic ingredient in SODIUM CHLORIDE 5% IN PLASTIC CONTAINER is sodium chloride. There are one thousand four hundred and fifty-four drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the sodium chloride profile page.
Summary for 019635
Tradename:SODIUM CHLORIDE 5% IN PLASTIC CONTAINER
Applicant:B Braun
Ingredient:sodium chloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 019635
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 019635 NDA B. Braun Medical Inc. 0264-7800 0264-7800-01 10 CONTAINER in 1 CARTON (0264-7800-01) > 500 mL in 1 CONTAINER
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 019635 NDA B. Braun Medical Inc. 0264-7800 0264-7800-90 10 CONTAINER in 1 CARTON (0264-7800-90) > 1000 mL in 1 CONTAINER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength450MG/100ML
Approval Date:Mar 9, 1988TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength900MG/100ML
Approval Date:Mar 9, 1988TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength3GM/100ML
Approval Date:Mar 9, 1988TE:APRLD:No

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