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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
UBS
Chinese Patent Office
Deloitte
Cerilliant
Johnson and Johnson
Merck
Fuji
Dow

Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021623

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NDA 021623 describes SYNERA, which is a drug marketed by Galen Specialty and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the SYNERA profile page.

The generic ingredient in SYNERA is lidocaine; tetracaine. There are twenty-nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the lidocaine; tetracaine profile page.
Summary for 021623
Tradename:SYNERA
Applicant:Galen Specialty
Ingredient:lidocaine; tetracaine
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 021623
Ingredient-typeAmides
Esters
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 021623
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SYNERA lidocaine; tetracaine PATCH;TOPICAL 021623 NDA Galen US Incorporated 10885-002 N 10885-002-01
SYNERA lidocaine; tetracaine PATCH;TOPICAL 021623 NDA Galen US Incorporated 10885-002 N 10885-002-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:PATCH;TOPICALStrength70MG;70MG
Approval Date:Jun 23, 2005TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jul 7, 2020Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021623

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galen Specialty SYNERA lidocaine; tetracaine PATCH;TOPICAL 021623-001 Jun 23, 2005 ➤ Sign Up ➤ Sign Up
Galen Specialty SYNERA lidocaine; tetracaine PATCH;TOPICAL 021623-001 Jun 23, 2005 ➤ Sign Up ➤ Sign Up
Galen Specialty SYNERA lidocaine; tetracaine PATCH;TOPICAL 021623-001 Jun 23, 2005 ➤ Sign Up ➤ Sign Up
Galen Specialty SYNERA lidocaine; tetracaine PATCH;TOPICAL 021623-001 Jun 23, 2005 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Express Scripts
Colorcon
Baxter
Merck
Deloitte
McKesson
AstraZeneca
Covington

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