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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 six 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 seventeen 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 NDA: 006488

Tradename:
XYLOCAINE
Applicant:
Fresenius Kabi Usa
Ingredient:
lidocaine hydrochloride
Patents:0
Therapeutic Class:Anesthetics
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 Rebel Distributors Corp 21695-466 21695-466-20 20 mL in 1 VIAL, MULTI-DOSE (21695-466-20)
XYLOCAINE
lidocaine hydrochloride
INJECTABLE;INJECTION 006488 NDA General Injectables & Vaccines, Inc 52584-481 52584-481-57 1 VIAL in 1 BAG (52584-481-57) > 50 mL in 1 VIAL

Summary for product number 002

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

Summary for product number 003

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

Summary 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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