Product Details for NDA 021513
ENABLEX (DARIFENACIN HYDROBROMIDE)
EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DARIFENACIN HYDROBROMIDE
Proprietary Name: ENABLEX
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021513
Product Number: 001
Approval Date: Dec 22, 2004
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
ENABLEX (DARIFENACIN HYDROBROMIDE)
Proprietary Name: ENABLEX
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021513
Product Number: 001
Approval Date: Dec 22, 2004
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DARIFENACIN HYDROBROMIDE
Proprietary Name: ENABLEX
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021513
Product Number: 002
Approval Date: Dec 22, 2004
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ENABLEX
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021513
Product Number: 002
Approval Date: Dec 22, 2004
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Discontinued
Patent and Exclusivity Information