Details for New Drug Application (NDA): 218138

NDA 218138 describes LIDOCAINE HYDROCHLORIDE VISCOUS, which is a drug marketed by Actavis Mid Atlantic, Chartwell Molecular, Intl Medication, and Pai Holdings Pharm, and is included in four NDAs. It is available from five suppliers. Additional details are available on the LIDOCAINE HYDROCHLORIDE VISCOUS profile page.

The generic ingredient in LIDOCAINE HYDROCHLORIDE VISCOUS is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.

Summary for 218138

Tradename:	LIDOCAINE HYDROCHLORIDE VISCOUS
Applicant:	Pai Holdings Pharm
Ingredient:	lidocaine hydrochloride
Patents:	0

Pharmacology for NDA: 218138

Physiological Effect

Local Anesthesia

Suppliers and Packaging for NDA: 218138

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LIDOCAINE HYDROCHLORIDE VISCOUS	lidocaine hydrochloride	SOLUTION;ORAL	218138	ANDA	PAI Holdings, LLC	0121-0950	0121-0950-03	12 BOTTLE in 1 CASE (0121-0950-03) / 100 mL in 1 BOTTLE
LIDOCAINE HYDROCHLORIDE VISCOUS	lidocaine hydrochloride	SOLUTION;ORAL	218138	ANDA	PAI Holdings, LLC	0121-4950	0121-4950-40	4 TRAY in 1 CASE (0121-4950-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-4950-15)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	2%
Approval Date:	Feb 20, 2024	TE:	AT	RLD:	No

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