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Generated: December 18, 2018

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Details for New Drug Application (NDA): 020849

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NDA 020849 describes PROSOL 20% 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 PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER profile page.

The generic ingredient in PROSOL 20% 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 020849
Tradename:PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER
Applicant:Baxter Hlthcare
Ingredient:amino acids
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020849
Suppliers and Packaging for NDA: 020849
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER amino acids INJECTABLE;INJECTION 020849 NDA Baxter Healthcare Corporation 0338-0499 0338-0499-06 2000 mL in 1 BAG (0338-0499-06)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20% (20GM/100ML)
Approval Date:Aug 26, 1998TE:RLD:Yes

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Federal Trade Commission
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