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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
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Express Scripts
Harvard Business School
Argus Health
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Generated: January 17, 2018

DrugPatentWatch Database Preview

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 seven 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 nineteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the epinephrine; lidocaine hydrochloride profile page.
Summary for 006488
Applicant:Fresenius Kabi Usa
Ingredient:epinephrine; lidocaine hydrochloride
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 RX PHARMA-PACK, INC. 49836-003 49836-003-18 1 KIT in 1 PACKAGE, COMBINATION (49836-003-18) * 10 mL in 1 VIAL, SINGLE-DOSE * 6.5 mL in 1 PACKET * .55 mL in 1 POUCH * 5 mL in 1 VIAL, SINGLE-DOSE

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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Serving leading biopharmaceutical companies globally:

Farmers Insurance
US Army
Harvard Business School
Boehringer Ingelheim
Express Scripts

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