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Last Updated: November 30, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 213253

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NDA 213253 describes LIDOCAINE AND PRILOCAINE, which is a drug marketed by Acrux Dds Pty, Akorn, Fougera Pharms, Rhodes Pharms, Teligent, and Tolmar, and is included in six NDAs. It is available from nine 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. Thirteen suppliers are listed for this compound. Additional details are available on the lidocaine; prilocaine profile page.
Summary for 213253
Applicant:Rhodes Pharms
Ingredient:lidocaine; prilocaine
Pharmacology for NDA: 213253
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 213253
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIDOCAINE AND PRILOCAINE lidocaine; prilocaine CREAM;TOPICAL 213253 ANDA Rhodes Pharmaceuticals 42858-029 42858-029-33 1 TUBE in 1 CARTON (42858-029-33) > 30 g in 1 TUBE
LIDOCAINE AND PRILOCAINE lidocaine; prilocaine CREAM;TOPICAL 213253 ANDA Rhodes Pharmaceuticals 42858-029 42858-029-55 5 TUBE in 1 CARTON (42858-029-55) > 5 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CREAM;TOPICALStrength2.5%;2.5%
Approval Date:Sep 21, 2020TE:RLD:No

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