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Serving leading biopharmaceutical companies globally:

Novartis
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Cipla
McKinsey
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Express Scripts
Merck
Colorcon
US Department of Justice
Daiichi Sankyo

Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076320

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NDA 076320 describes LIDOCAINE AND PRILOCAINE, which is a drug marketed by Fougera Pharms, Hi Tech Pharma, and Tolmar, and is included in three NDAs. It is available from fourteen suppliers. Additional details are available on the LIDOCAINE AND PRILOCAINE profile page.

The generic ingredient in LIDOCAINE AND PRILOCAINE is lidocaine; prilocaine. There are twenty-nine drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the lidocaine; prilocaine profile page.
Summary for 076320
Tradename:LIDOCAINE AND PRILOCAINE
Applicant:Tolmar
Ingredient:lidocaine; prilocaine
Patents:0
Therapeutic Class:Anesthetics
Formulation / Manufacturing:see details
Pharmacology for NDA: 076320
Ingredient-typeAmides
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 076320
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIDOCAINE AND PRILOCAINE lidocaine; prilocaine CREAM;TOPICAL 076320 ANDA Impax Generics 0115-1468 N 0115-1468-60
LIDOCAINE AND PRILOCAINE lidocaine; prilocaine CREAM;TOPICAL 076320 ANDA Impax Generics 0115-1468 N 0115-1468-45

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength2.5%;2.5%
Approval Date:Aug 27, 2003TE:ABRLD:No

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Farmers Insurance
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Fish and Richardson

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