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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077006

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NDA 077006 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 077006
Tradename:TOLTERODINE TARTRATE
Applicant:Ivax Sub Teva Pharms
Ingredient:tolterodine tartrate
Patents:0
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 077006
Medical Subject Heading (MeSH) Categories for 077006
Suppliers and Packaging for NDA: 077006
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOLTERODINE TARTRATE tolterodine tartrate TABLET;ORAL 077006 ANDA Teva Pharmaceuticals USA Inc 0093-0010 N 0093-0010-05
TOLTERODINE TARTRATE tolterodine tartrate TABLET;ORAL 077006 ANDA Teva Pharmaceuticals USA Inc 0093-0010 N 0093-0010-06

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Feb 23, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Feb 23, 2015TE:ABRLD:No

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