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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Farmers Insurance

Generated: March 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203016

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NDA 203016 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 203016
Applicant:Torrent Pharms Ltd
Ingredient:tolterodine tartrate
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203016
Medical Subject Heading (MeSH) Categories for 203016
Suppliers and Packaging for NDA: 203016
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOLTERODINE TARTRATE tolterodine tartrate CAPSULE, EXTENDED RELEASE;ORAL 203016 ANDA Major Pharmaceuticals 0904-6592 N 0904-6592-04
TOLTERODINE TARTRATE tolterodine tartrate CAPSULE, EXTENDED RELEASE;ORAL 203016 ANDA Major Pharmaceuticals 0904-6593 N 0904-6593-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength2MG
Approval Date:Aug 11, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength4MG
Approval Date:Aug 11, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
US Army
Fish and Richardson
Queensland Health

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