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Serving 500+ biopharmaceutical companies globally:

McKinsey
McKesson
Boehringer Ingelheim
US Department of Justice
Farmers Insurance
Moodys
Fuji
Cerilliant
QuintilesIMS
Cipla

Generated: June 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019438

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NDA 019438 describes AMINOSYN II 8.5%, which is a drug marketed by Icu Medical Inc and is included in two NDAs. It is available from one supplier. Additional details are available on the AMINOSYN II 8.5% profile page.

The generic ingredient in AMINOSYN II 8.5% is amino acids; magnesium chloride; potassium chloride; potassium phosphate, dibasic; sodium chloride. There are three hundred and thirty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amino acids; magnesium chloride; potassium chloride; potassium phosphate, dibasic; sodium chloride profile page.

Summary for NDA: 019438

Tradename:
5
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 019438

Ingredient-typeAmino Acids

Suppliers and Packaging for NDA: 019438

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMINOSYN II 10%
amino acids
INJECTABLE;INJECTION 019438 NDA Hospira, Inc. 0409-4162 0409-4162-03 12 POUCH in 1 CASE (0409-4162-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG
AMINOSYN II 3.5%
amino acids
INJECTABLE;INJECTION 019438 NDA Hospira, Inc. 0409-4162 0409-4162-03 12 POUCH in 1 CASE (0409-4162-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength3.5% (3.5GM/100ML)
Approval Date:Apr 3, 1986TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength5% (5GM/100ML)
Approval Date:Apr 3, 1986TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength7% (7GM/100ML)
Approval Date:Apr 3, 1986TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Medtronic
Farmers Insurance
Express Scripts
Daiichi Sankyo
Colorcon
US Army
Argus Health
Mallinckrodt
Citi
Boehringer Ingelheim

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