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Last Updated: June 16, 2021

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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 fifty drug master file entries for this compound. Four 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
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 leading biopharmaceutical companies globally:

Boehringer Ingelheim

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