General MedicationsORALGeneric

ENABLEX

DARIFENACIN HYDROBROMIDE

Standard Dose

EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Discontinued

Summary

Approval overview ENABLEX is listed in Drugs@FDA under application 021513 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient DARIFENACIN HYDROBROMIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ABBVIE Submission history Latest submission status date: 2021-07-14 00:00:00.

Structured Monograph

Clinical summary

Approval overview ENABLEX is listed in Drugs@FDA under application 021513 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient DARIFENACIN HYDROBROMIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ABBVIE Submission history Latest submission status date: 2021-07-14 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.