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Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203409

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NDA 203409 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 twelve 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. Sixteen suppliers are listed for this compound. Additional details are available on the tolterodine tartrate profile page.
Summary for 203409
Tradename:TOLTERODINE TARTRATE
Applicant:Macleods Pharms Ltd
Ingredient:tolterodine tartrate
Patents:0
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203409
Medical Subject Heading (MeSH) Categories for 203409
Suppliers and Packaging for NDA: 203409
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOLTERODINE TARTRATE tolterodine tartrate TABLET;ORAL 203409 ANDA Macleods Pharmaceuticals Limited 33342-097 N 33342-097-15
TOLTERODINE TARTRATE tolterodine tartrate TABLET;ORAL 203409 ANDA Macleods Pharmaceuticals Limited 33342-097 N 33342-097-12

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Aug 31, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Aug 31, 2015TE:ABRLD:No

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