Drug Index

DARIFENACIN HYDROBROMIDE

Generic: DARIFENACIN HYDROBROMIDE

Review priority: STANDARD Marketing status: Prescription

Route: ORAL
Class: General Medications
Safety profile: routine
Latest regulatory update: 06 Jan 2020, 12:00 am (UTC)

Structured Monograph

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 7.5MG BASE Sponsor PURACAP LABS BLU Submission history Latest submission status date: 2020-01-06 00:00:00. Submission type: ORIG.