General MedicationsORALStandard

DARIFENACIN HYDROBROMIDE

Standard Dose

EQ 15MG BASE

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview DARIFENACIN HYDROBROMIDE is listed in Drugs@FDA under application 211045 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DARIFENACIN HYDROBROMIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - EQ 15MG BASE Sponsor PURACAP LABS BLU Submission history Latest submission status date: 2020-01-06 00:00:00.

Structured Monograph

Clinical summary

Approval overview DARIFENACIN HYDROBROMIDE is listed in Drugs@FDA under application 211045 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DARIFENACIN HYDROBROMIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - EQ 15MG BASE Sponsor PURACAP LABS BLU Submission history Latest submission status date: 2020-01-06 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.