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Generated: November 17, 2018

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Details for New Drug Application (NDA): 020512

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NDA 020512 describes CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and is included in one NDA. It is available from one supplier. Additional details are available on the CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER profile page.

The generic ingredient in CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER is amino acids. There are three hundred and forty-eight 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 020512
Tradename:CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER
Applicant:Baxter Hlthcare
Ingredient:amino acids
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020512
Ingredient-typeAmino Acids
Suppliers and Packaging for NDA: 020512
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER amino acids INJECTABLE;INJECTION 020512 ANDA Baxter Healthcare Corporation 0338-0502 0338-0502-03 500 mL in 1 BAG (0338-0502-03)
CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER amino acids INJECTABLE;INJECTION 020512 ANDA Baxter Healthcare Corporation 0338-0502 0338-0502-06 2000 mL in 1 BAG (0338-0502-06)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength15% (15GM/100ML)
Approval Date:Aug 30, 1996TE:RLD:No

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