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Serving leading biopharmaceutical companies globally:

Argus Health
Harvard Business School
Queensland Health
US Army
Johnson and Johnson
Daiichi Sankyo
Farmers Insurance

Generated: November 18, 2017

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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 forty-one 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

Formulation / Manufacturing:see details

Pharmacology for NDA: 091112

Ingredient-typeAmino Acids

Suppliers and Packaging for NDA: 091112

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
amino acids
INJECTABLE;INJECTION 091112 ANDA B. Braun Medical Inc. 0264-3200 0264-3200-55 6 CARTON in 1 CASE (0264-3200-55) > 1 BOTTLE, GLASS in 1 CARTON > 1000 mL in 1 BOTTLE, GLASS
amino acids
INJECTABLE;INJECTION 091112 ANDA B. Braun Medical Inc. 0264-3205 0264-3205-55 6 CARTON in 1 CASE (0264-3205-55) > 1 BOTTLE, GLASS in 1 CARTON > 2000 mL in 1 BOTTLE, GLASS

Summary for product number 001

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

Summary for product number 002

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

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Serving leading biopharmaceutical companies globally:

Queensland Health
Cantor Fitzgerald
Boehringer Ingelheim
Federal Trade Commission

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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