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Last Updated: December 11, 2019

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 two 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. Twelve 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
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 0430-0170-00 337500 TABLET, EXTENDED RELEASE in 1 DRUM (0430-0170-00)
ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513 NDA Allergan, Inc. 0430-0170 0430-0170-15 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0430-0170-15)
Paragraph IV (Patent) Challenges for 021513
Tradename Dosage Ingredient NDA Submissiondate
ENABLEX TABLET, EXTENDED RELEASE;ORAL darifenacin hydrobromide 021513 2008-12-22

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

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