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Generated: October 23, 2018

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Details for New Drug Application (NDA): 091190

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NDA 091190 describes DARIFENACIN HYDROBROMIDE, which is a drug marketed by Alembic Pharms Ltd, Anchen Pharms, Aurobindo Pharma Ltd, Cipla Ltd, Jubilant Generics, and Torrent Pharms Ltd, and is included in six NDAs. It is available from nine suppliers. Additional details are available on the DARIFENACIN HYDROBROMIDE profile page.

The generic ingredient in DARIFENACIN HYDROBROMIDE is darifenacin hydrobromide. There are nineteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the darifenacin hydrobromide profile page.
Summary for 091190
Tradename:DARIFENACIN HYDROBROMIDE
Applicant:Anchen Pharms
Ingredient:darifenacin hydrobromide
Patents:0
Pharmacology for NDA: 091190
Suppliers and Packaging for NDA: 091190
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DARIFENACIN HYDROBROMIDE darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 091190 ANDA Par Pharmaceutical, Inc. 10370-170 10370-170-09 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (10370-170-09)
DARIFENACIN HYDROBROMIDE darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 091190 ANDA Par Pharmaceutical, Inc. 10370-170 10370-170-11 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10370-170-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 7.5MG BASE
Approval Date:Mar 13, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 15MG BASE
Approval Date:Mar 13, 2015TE:ABRLD:No

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