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Generated: May 25, 2017

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Details for New Drug Application (NDA): 076320

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NDA 076320 describes LIDOCAINE AND PRILOCAINE, which is a drug marketed by Tolmar, Fougera Pharms, and Hi Tech Pharma, and is included in three NDAs. It is available from fifteen 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-seven suppliers are listed for this compound. Additional details are available on the lidocaine; prilocaine profile page.

Summary for NDA: 076320

Therapeutic Class:Anesthetics
Formulation / Manufacturing:see details

Pharmacology for NDA: 076320

Physiological EffectLocal Anesthesia

Suppliers and Packaging for NDA: 076320

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
lidocaine; prilocaine
CREAM;TOPICAL 076320 ANDA Impax Generics 0115-1468 0115-1468-45 1 TUBE in 1 CARTON (0115-1468-45) > 30 g in 1 TUBE
lidocaine; prilocaine
CREAM;TOPICAL 076320 ANDA Impax Generics 0115-1468 0115-1468-53 1 TUBE in 1 CARTON (0115-1468-53) > 5 g in 1 TUBE

Summary 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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