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Last Updated: March 15, 2025

Details for New Drug Application (NDA): 076320

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NDA 076320 describes LIDOCAINE AND PRILOCAINE, which is a drug marketed by Alembic, Encube, Fougera Pharms, Hikma, Padagis Us, Pai Holdings Pharm, Rhodes Pharms, and Zydus Lifesciences, and is included in eight NDAs. It is available from twelve 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. Fourteen suppliers are listed for this compound. Additional details are available on the lidocaine; prilocaine profile page.

Summary for 076320

Tradename:	LIDOCAINE AND PRILOCAINE
Applicant:	Encube
Ingredient:	lidocaine; prilocaine
Patents:	0

Pharmacology for NDA: 076320

Physiological Effect	Local 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	Encube Ethicals Private Limited	21922-076	21922-076-05	1 TUBE in 1 CARTON (21922-076-05) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	2.5%;2.5%
Approval Date:	Aug 27, 2003	TE:	AB	RLD:	No

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