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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Farmers Insurance
Johnson and Johnson

Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206743

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NDA 206743 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. Thirteen suppliers are listed for this compound. Additional details are available on the darifenacin hydrobromide profile page.
Summary for 206743
Applicant:Aurobindo Pharma Ltd
Ingredient:darifenacin hydrobromide
Therapeutic Class:Genitourinary Agents
Pharmacology for NDA: 206743
Suppliers and Packaging for NDA: 206743
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DARIFENACIN HYDROBROMIDE darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 206743 ANDA Aurobindo Pharma Limited 65862-861 N 65862-861-05
DARIFENACIN HYDROBROMIDE darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 206743 ANDA Aurobindo Pharma Limited 65862-861 N 65862-861-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 7.5MG BASE
Approval Date:Sep 19, 2016TE:ABRLD:No

Profile for product number 002

Approval Date:Sep 19, 2016TE:ABRLD:No

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