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Details for New Drug Application (NDA): 076453

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NDA 076453 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 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-three suppliers are listed for this compound. Additional details are available on the lidocaine; prilocaine profile page.

Summary for NDA: 076453

Fougera Pharms
lidocaine; prilocaine
Therapeutic Class:Anesthetics
Formulation / Manufacturing:see details

Pharmacology for NDA: 076453

Physiological EffectLocal Anesthesia

Suppliers and Packaging for NDA: 076453

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
lidocaine; prilocaine
CREAM;TOPICAL 076453 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0357 0168-0357-30 1 TUBE in 1 CARTON (0168-0357-30) > 30 g in 1 TUBE
lidocaine; prilocaine
CREAM;TOPICAL 076453 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0357 0168-0357-55 1 TUBE in 1 CARTON (0168-0357-55) > 5 g in 1 TUBE (0168-0357-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength2.5%;2.5%
Approval Date:Aug 18, 2003TE:ABRLD:No

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