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Serving hundreds of leading biopharmaceutical companies globally:

US Army
UBS
Johnson and Johnson
Colorcon
Deloitte
Queensland Health
US Department of Justice
Medtronic
Julphar

Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021513

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NDA 021513 describes ENABLEX, which is a drug marketed by Apil and is included in one NDA. It is available from three suppliers. Additional details are available on the ENABLEX profile page.

The generic ingredient in ENABLEX is darifenacin hydrobromide. There are nineteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the darifenacin hydrobromide profile page.
Summary for 021513
Tradename:ENABLEX
Applicant:Apil
Ingredient:darifenacin hydrobromide
Patents:0
Therapeutic Class:Genitourinary Agents
Pharmacology for NDA: 021513
Suppliers and Packaging for NDA: 021513
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513 NDA Allergan, Inc. 0430-0170 N 0430-0170-00
ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513 NDA Allergan, Inc. 0430-0170 N 0430-0170-15

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 7.5MG BASE
Approval Date:Dec 22, 2004TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 15MG BASE
Approval Date:Dec 22, 2004TE:ABRLD:Yes

Expired US Patents for NDA 021513

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-002 Dec 22, 2004 ➤ Sign Up ➤ Sign Up
Apil ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-001 Dec 22, 2004 ➤ Sign Up ➤ Sign Up
Apil ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-002 Dec 22, 2004 ➤ Sign Up ➤ Sign Up
Apil ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-001 Dec 22, 2004 ➤ 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:

Accenture
Fuji
Queensland Health
Julphar
AstraZeneca
Daiichi Sankyo
Farmers Insurance
Federal Trade Commission
Moodys

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