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Last Updated: September 26, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079141

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NDA 079141 describes TOLTERODINE TARTRATE, which is a drug marketed by Ajanta Pharma Ltd, Hetero Labs Ltd Iii, Inventia Hlthcare, Mylan, Teva Pharms Usa, Torrent, Apotex Corp, Invatech, Ivax Sub Teva Pharms, Macleods Pharms Ltd, Mylan Pharms Inc, Unichem Labs Ltd, and Unique Pharm Labs, and is included in thirteen NDAs. It is available from seventeen 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. Twenty suppliers are listed for this compound. Additional details are available on the tolterodine tartrate profile page.
Summary for 079141
Tradename:TOLTERODINE TARTRATE
Applicant:Teva Pharms Usa
Ingredient:tolterodine tartrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 079141
Medical Subject Heading (MeSH) Categories for 079141
Suppliers and Packaging for NDA: 079141
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOLTERODINE TARTRATE tolterodine tartrate CAPSULE, EXTENDED RELEASE;ORAL 079141 ANDA Teva Pharmaceuticals USA, Inc. 0093-7163 0093-7163-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-7163-05)
TOLTERODINE TARTRATE tolterodine tartrate CAPSULE, EXTENDED RELEASE;ORAL 079141 ANDA Teva Pharmaceuticals USA, Inc. 0093-7163 0093-7163-56 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-7163-56)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength2MG
Approval Date:Nov 22, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength4MG
Approval Date:Nov 22, 2016TE:ABRLD:No

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