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Generated: December 14, 2018

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Details for New Drug Application (NDA): 017865

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NDA 017865 describes AMINOACETIC ACID 1.5% 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 AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER profile page.

The generic ingredient in AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER is glycine. There are thirty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the glycine profile page.
Summary for 017865
Applicant:Baxter Hlthcare
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 017865
Suppliers and Packaging for NDA: 017865
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER glycine SOLUTION;IRRIGATION 017865 NDA Baxter Healthcare Corporation 0338-0289 0338-0289-47 3000 mL in 1 BAG (0338-0289-47)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IRRIGATIONStrength1.5GM/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:Yes

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