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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
Argus Health

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076290

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NDA 076290 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 076290
Applicant:Hi Tech Pharma
Ingredient:lidocaine; prilocaine
Therapeutic Class:Anesthetics
Formulation / Manufacturing:see details
Pharmacology for NDA: 076290
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 076290
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIDOCAINE AND PRILOCAINE lidocaine; prilocaine CREAM;TOPICAL 076290 ANDA Aidarex Pharmaceuticals LLC 33261-591 33261-591-01 1 TUBE in 1 CARTON (33261-591-01) > 30 g in 1 TUBE
LIDOCAINE AND PRILOCAINE lidocaine; prilocaine CREAM;TOPICAL 076290 ANDA Rebel Distributors Corp 42254-195 42254-195-30 1 TUBE in 1 CARTON (42254-195-30) > 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength2.5%;2.5%
Approval Date:Sep 25, 2003TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Argus Health

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