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Serving leading biopharmaceutical companies globally:

Chubb
Cipla
Express Scripts
Healthtrust
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Generated: November 18, 2017

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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 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

Tradename:
2
Applicant:
1
Ingredient:
2
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 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

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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Serving leading biopharmaceutical companies globally:

AstraZeneca
Queensland Health
Chubb
Novartis
McKinsey
Accenture
Teva
UBS
Boehringer Ingelheim
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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