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Details for New Drug Application (NDA): 019438

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NDA 019438 describes AMINOSYN II 8.5%, which is a drug marketed by Hospira 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 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:
AMINOSYN II 10%
Applicant:
Hospira
Ingredient:
amino acids
Patents:0
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. 0409-4160 0409-4160-03 12 POUCH in 1 CASE (0409-4160-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG
AMINOSYN II 3.5%
amino acids
INJECTABLE;INJECTION 019438 NDA Hospira, Inc. 0409-4160 0409-4160-03 12 POUCH in 1 CASE (0409-4160-03) > 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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