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Generated: April 30, 2017

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Details for New Drug Application (NDA): 019374

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NDA 019374 describes AMINOSYN-HBC 7%, which is a drug marketed by Icu Medcl and Abbott and is included in two NDAs. It is available from one supplier. Additional details are available on the AMINOSYN-HBC 7% profile page.

The generic ingredient in AMINOSYN-HBC 7% is amino acids. There are three hundred and thirty-six 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 NDA: 019374

Formulation / Manufacturing:see details

Pharmacology for NDA: 019374

Ingredient-typeAmino Acids

Suppliers and Packaging for NDA: 019374

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
amino acids
INJECTABLE;INJECTION 019374 NDA Hospira, Inc. 0409-4168 0409-4168-03 12 POUCH in 1 CASE (0409-4168-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG
amino acids
INJECTABLE;INJECTION 019374 NDA Hospira, Inc. 0409-4168 0409-4168-05 6 POUCH in 1 CASE (0409-4168-05) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength7% (7GM/100ML)
Approval Date:Jul 12, 1985TE:RLD:No

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