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Last Updated: June 13, 2021

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Details for New Drug Application (NDA): 018315

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NDA 018315 describes GLYCINE 1.5% IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Baxter Hlthcare, Hospira, and Icu Medical Inc, and is included in four NDAs. It is available from two suppliers. Additional details are available on the GLYCINE 1.5% IN PLASTIC CONTAINER profile page.

The generic ingredient in GLYCINE 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 018315
Applicant:Icu Medical Inc
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 018315
Suppliers and Packaging for NDA: 018315
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYCINE 1.5% IN PLASTIC CONTAINER glycine SOLUTION;IRRIGATION 018315 NDA ICU Medical Inc. 0990-7974 0990-7974-08 4 POUCH in 1 CASE (0990-7974-08) > 1 BAG in 1 POUCH > 3000 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IRRIGATIONStrength1.5GM/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:No

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Serving leading biopharmaceutical companies globally:

Express Scripts
Harvard Business School

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