Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 14, 2019

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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. Seventeen suppliers are listed for this compound. Additional details are available on the lidocaine; prilocaine profile page.
Summary for 021451
Applicant:Dentsply Pharm
Ingredient:lidocaine; prilocaine
Pharmacology for NDA: 021451
Physiological EffectLocal 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:RXDosage:GEL;PERIODONTALStrength2.5%;2.5%
Approval Date:Dec 19, 2003TE:RLD:Yes

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Harvard Business School

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