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Last Updated: August 11, 2022

Details for New Drug Application (NDA): 006488


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NDA 006488 describes XYLOCAINE W/ EPINEPHRINE, which is a drug marketed by Astrazeneca and Fresenius Kabi Usa and is included in two NDAs. It is available from eight suppliers. Additional details are available on the XYLOCAINE W/ EPINEPHRINE profile page.

The generic ingredient in XYLOCAINE W/ EPINEPHRINE is epinephrine; lidocaine hydrochloride. There are twenty-one drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the epinephrine; lidocaine hydrochloride profile page.
Summary for 006488
Tradename:XYLOCAINE W/ EPINEPHRINE
Applicant:Fresenius Kabi Usa
Ingredient:epinephrine; lidocaine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 006488
Suppliers and Packaging for NDA: 006488
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XYLOCAINE lidocaine hydrochloride INJECTABLE;INJECTION 006488 NDA Henry Schein, Inc. 0404-9972 0404-9972-20 1 VIAL in 1 BAG (0404-9972-20) > 20 mL in 1 VIAL
XYLOCAINE lidocaine hydrochloride INJECTABLE;INJECTION 006488 NDA Henry Schein, Inc. 0404-9973 0404-9973-20 1 VIAL in 1 BAG (0404-9973-20) > 20 mL in 1 VIAL

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2%
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength0.01MG/ML;2%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.01MG/ML;1%
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

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