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Serving leading biopharmaceutical companies globally:

Deloitte
Cipla
Queensland Health
Colorcon
AstraZeneca
Teva
Moodys
Cerilliant
Daiichi Sankyo
Harvard Business School

Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021383

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NDA 021383 describes CITANEST FORTE DENTAL, 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 CITANEST FORTE DENTAL profile page.

The generic ingredient in CITANEST FORTE DENTAL is epinephrine bitartrate; prilocaine hydrochloride. There are nineteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the epinephrine bitartrate; prilocaine hydrochloride profile page.
Summary for 021383
Tradename:CITANEST FORTE DENTAL
Applicant:Dentsply Pharm
Ingredient:epinephrine bitartrate; prilocaine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021383
Suppliers and Packaging for NDA: 021383
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CITANEST FORTE DENTAL epinephrine bitartrate; prilocaine hydrochloride INJECTABLE;INJECTION 021383 NDA Dentsply Pharmaceutical Inc. 66312-540 N 66312-540-14
CITANEST FORTE DENTAL epinephrine bitartrate; prilocaine hydrochloride INJECTABLE;INJECTION 021383 NDA Dentsply Pharmaceutical Inc. 66312-540 N 66312-540-16

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.005MG/ML;4%
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKinsey
Julphar
Deloitte
Covington
Teva
Argus Health
US Department of Justice
Express Scripts

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