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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 Aurobindo Pharma Ltd, Jubilant Generics, Cipla Ltd, and Anchen Pharms, and is included in four NDAs. It is available from four 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. Eight suppliers are listed for this compound. Additional details are available on the darifenacin hydrobromide profile page.

Summary for NDA: 091190

Tradename:
DARIFENACIN HYDROBROMIDE
Applicant:
Anchen Pharms
Ingredient:
darifenacin hydrobromide
Patents:0
Therapeutic Class:Genitourinary Agents

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 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 10370-170 10370-170-11 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10370-170-11)

Summary for product number 001

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

Summary 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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