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Generated: April 20, 2019

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Details for New Drug Application (NDA): 018523

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NDA 018523 describes ACETIC ACID 0.25% IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Baxter Hlthcare, and Icu Medical Inc, and is included in three NDAs. It is available from three suppliers. Additional details are available on the ACETIC ACID 0.25% IN PLASTIC CONTAINER profile page.

The generic ingredient in ACETIC ACID 0.25% IN PLASTIC CONTAINER is acetic acid, glacial. There are thirty-six drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the acetic acid, glacial profile page.
Summary for 018523
Applicant:Baxter Hlthcare
Ingredient:acetic acid, glacial
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 018523
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETIC ACID 0.25% IN PLASTIC CONTAINER acetic acid, glacial SOLUTION;IRRIGATION, URETHRAL 018523 NDA Baxter Healthcare Corporation 0338-0656 0338-0656-04 1000 mL in 1 BOTTLE, PLASTIC (0338-0656-04)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IRRIGATION, URETHRALStrength250MG/100ML
Approval Date:Feb 19, 1982TE:ATRLD:No

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