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Generated: November 22, 2018

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Details for New Drug Application (NDA): 018676

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NDA 018676 describes HEPATAMINE 8%, 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 HEPATAMINE 8% profile page.

The generic ingredient in HEPATAMINE 8% is amino acids. There are three hundred and forty-eight 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 018676
Tradename:HEPATAMINE 8%
Applicant:B Braun
Ingredient:amino acids
Formulation / Manufacturing:see details
Pharmacology for NDA: 018676
Ingredient-typeAmino Acids
Suppliers and Packaging for NDA: 018676
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HEPATAMINE 8% amino acids INJECTABLE;INJECTION 018676 NDA B. Braun Medical Inc. 0264-9371 0264-9371-55 6 CARTON in 1 CASE (0264-9371-55) > 1 CONTAINER in 1 CARTON > 500 mL in 1 CONTAINER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength8% (8GM/100ML)
Approval Date:Aug 3, 1982TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

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Fish and Richardson

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