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Generated: June 18, 2019

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Details for New Drug Application (NDA): 017766

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NDA 017766 describes NEPHRAMINE 5.4%, which is a drug marketed by B Braun and is included in one NDA. It is available from one supplier. Additional details are available on the NEPHRAMINE 5.4% profile page.

The generic ingredient in NEPHRAMINE 5.4% is amino acids. There are three hundred and fifty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the amino acids profile page.
Summary for 017766
Tradename:NEPHRAMINE 5.4%
Applicant:B Braun
Ingredient:amino acids
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 017766
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEPHRAMINE 5.4% amino acids INJECTABLE;INJECTION 017766 NDA B. Braun Medical Inc. 0264-1909 0264-1909-55 12 CARTON in 1 CASE (0264-1909-55) > 1 CONTAINER in 1 CARTON > 250 mL in 1 CONTAINER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5.4% (5.4GM/100ML)
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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