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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 four suppliers. There is one patent protecting this drug and one Paragraph IV challenge. 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. Eight suppliers are listed for this compound. Additional details are available on the darifenacin hydrobromide profile page.

Summary for NDA: 021513

Tradename:
ENABLEX
Applicant:
Apil
Ingredient:
darifenacin hydrobromide
Patents:1
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 Warner Chilcott (US), LLC 0430-0170 0430-0170-00 337500 TABLET, EXTENDED RELEASE in 1 DRUM (0430-0170-00)
ENABLEX
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL 021513 NDA Warner Chilcott (US), LLC 0430-0170 0430-0170-15 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0430-0170-15)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 7.5MG BASE
Approval Date:Dec 22, 2004TE:ABRLD:No
Patent:6,106,864Patent Expiration:Aug 21, 2016Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATING URINARY INCONTINENCE BY ADMINISTERING AN EXTENDED-RELEASE FORM OF DARIFENACIN

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 15MG BASE
Approval Date:Dec 22, 2004TE:ABRLD:Yes
Patent:6,106,864Patent Expiration:Aug 21, 2016Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATING URINARY INCONTINENCE BY ADMINISTERING AN EXTENDED-RELEASE FORM OF DARIFENACIN

Expired Orange Book Patents for NDA: 021513

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil
ENABLEX
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL021513-001Dec 22, 20045,096,890► subscribe
Apil
ENABLEX
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL021513-002Dec 22, 20046,106,864► subscribe
Apil
ENABLEX
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL021513-002Dec 22, 20045,096,890► subscribe
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