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Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 083158

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NDA 083158 describes LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%, which is a drug marketed by Hospira and is included in two NDAs. It is available from four suppliers. Additional details are available on the LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% profile page.

The generic ingredient in LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.
Summary for 083158
Tradename:LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%
Applicant:Hospira
Ingredient:lidocaine hydrochloride
Patents:0
Therapeutic Class:Anesthetics
Formulation / Manufacturing:see details
Pharmacology for NDA: 083158
Ingredient-typeAmides
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 083158
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride INJECTABLE;INJECTION 083158 ANDA Hospira, Inc. 0409-4903 N 0409-4903-34
LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride INJECTABLE;INJECTION 083158 ANDA Hospira, Inc. 0409-4904 N 0409-4904-34

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1%
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2%
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20%
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

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US Department of Justice
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