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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 219120

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NDA 219120 describes LIDOCAINE AND PRILOCAINE, which is a drug marketed by Alembic, Chartwell Rx, Encube, Fougera Pharms, Hikma, Padagis Us, Pai Holdings Pharm, and Zydus Lifesciences, and is included in eight 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. Fifteen suppliers are listed for this compound. Additional details are available on the lidocaine; prilocaine profile page.

Summary for 219120

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

Pharmacology for NDA: 219120

Physiological Effect	Local Anesthesia

Suppliers and Packaging for NDA: 219120

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LIDOCAINE AND PRILOCAINE	lidocaine; prilocaine	CREAM;TOPICAL	219120	ANDA	Zydus Lifesciences Limited	70771-1872	70771-1872-2	1 TUBE in 1 CARTON (70771-1872-2) / 30 g in 1 TUBE
LIDOCAINE AND PRILOCAINE	lidocaine; prilocaine	CREAM;TOPICAL	219120	ANDA	Zydus Lifesciences Limited	70771-1872	70771-1872-8	5 TUBE in 1 CARTON (70771-1872-8) / 5 g in 1 TUBE (70771-1872-5)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	2.5%;2.5%
Approval Date:	Dec 17, 2024	TE:	AB	RLD:	No

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