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Last Updated: July 19, 2024

Details for New Drug Application (NDA): 091112


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NDA 091112 describes AMINO ACIDS, 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 AMINO ACIDS profile page.

The generic ingredient in AMINO ACIDS is amino acids. There are three hundred and fifty 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 091112
Tradename:AMINO ACIDS
Applicant:B Braun
Ingredient:amino acids
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 091112
Suppliers and Packaging for NDA: 091112
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMINO ACIDS amino acids INJECTABLE;INJECTION 091112 ANDA B. Braun Medical Inc. 0264-4500 0264-4500-00 8 CONTAINER in 1 CASE (0264-4500-00) / 1000 mL in 1 CONTAINER
AMINO ACIDS amino acids INJECTABLE;INJECTION 091112 ANDA B. Braun Medical Inc. 0264-4500 0264-4500-05 4 CONTAINER in 1 CASE (0264-4500-05) / 2000 mL in 1 CONTAINER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength15%(150GM/1000ML)
Approval Date:Apr 13, 2012TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength15%(300GM/2000ML)
Approval Date:Apr 13, 2012TE:RLD:No

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