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Last Updated: April 25, 2024

Details for New Drug Application (NDA): 021451

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NDA 021451 describes ORAQIX, which is a drug marketed by Dentsply Pharm and is included in one NDA. It is available from one supplier. Additional details are available on the ORAQIX profile page.

The generic ingredient in ORAQIX 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 021451

Tradename:	ORAQIX
Applicant:	Dentsply Pharm
Ingredient:	lidocaine; prilocaine
Patents:	0

Pharmacology for NDA: 021451

Physiological Effect	Local Anesthesia

Suppliers and Packaging for NDA: 021451

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ORAQIX	lidocaine; prilocaine	GEL;PERIODONTAL	021451	NDA	Dentsply Pharmaceutical	66312-110	66312-110-20	20 APPLICATOR in 1 CARTON (66312-110-20) / 1 CARTRIDGE in 1 APPLICATOR / 1.7 g in 1 CARTRIDGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;PERIODONTAL			Strength	2.5%;2.5%
Approval Date:	Dec 19, 2003	TE:		RLD:	Yes

Expired US Patents for NDA 021451

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Dentsply Pharm	ORAQIX	lidocaine; prilocaine	GEL;PERIODONTAL	021451-001	Dec 19, 2003	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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