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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
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Cantor Fitzgerald
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Generated: March 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202641

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NDA 202641 describes TOLTERODINE TARTRATE, which is a drug marketed by Hetero Labs Ltd Iii, Mylan Pharms Inc, Teva Pharms Usa, Torrent Pharms Ltd, Apotex Corp, Ivax Sub Teva Pharms, and Macleods Pharms Ltd, and is included in eight NDAs. It is available from thirteen suppliers. Additional details are available on the TOLTERODINE TARTRATE profile page.

The generic ingredient in TOLTERODINE TARTRATE is tolterodine tartrate. There are twenty-three drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the tolterodine tartrate profile page.
Summary for 202641
Applicant:Mylan Pharms Inc
Ingredient:tolterodine tartrate
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 202641
Medical Subject Heading (MeSH) Categories for 202641
Suppliers and Packaging for NDA: 202641
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOLTERODINE TARTRATE tolterodine tartrate TABLET;ORAL 202641 ANDA Mylan Institutional Inc. 51079-235 N 51079-235-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Nov 27, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Nov 27, 2012TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Cantor Fitzgerald
US Army
Harvard Business School

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