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BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Obtain formulation and manufacturing information

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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Express Scripts
Teva
Mallinckrodt
Dow
Cerilliant
Queensland Health
McKesson
Argus Health
Chinese Patent Office

Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207664

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NDA 207664 describes DARIFENACIN HYDROBROMIDE, which is a drug marketed by Anchen Pharms, Aurobindo Pharma Ltd, Cipla Ltd, Jubilant Generics, and Torrent Pharms Ltd, and is included in five NDAs. It is available from seven 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. Eleven suppliers are listed for this compound. Additional details are available on the darifenacin hydrobromide profile page.

Summary for 207664

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Genitourinary Agents

Pharmacology for NDA: 207664

Suppliers and Packaging for NDA: 207664

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DARIFENACIN HYDROBROMIDE darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 207664 ANDA Cipla USA Inc. 69097-431 69097-431-02 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-431-02)
DARIFENACIN HYDROBROMIDE darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 207664 ANDA Cipla USA Inc. 69097-431 69097-431-05 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-431-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 7.5MG BASE
Approval Date:Sep 1, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 15MG BASE
Approval Date:Sep 1, 2016TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Covington
Merck
Teva
Baxter
QuintilesIMS
Deloitte
Moodys
Chinese Patent Office
Citi
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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