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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 077006


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NDA 077006 describes TOLTERODINE TARTRATE, which is a drug marketed by Ajanta Pharma Ltd, Aurobindo Pharma Usa, Hetero Labs Ltd Iii, Inventia Hlthcare, Teva Pharms Usa, Torrent, Unichem, Utopic Pharms, Apotex Corp, Elysium, Hetero Labs Ltd V, Ivax Sub Teva Pharms, Macleods Pharms Ltd, Norvium Bioscience, and Unique, and is included in sixteen NDAs. It is available from sixteen 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 077006
Tradename:TOLTERODINE TARTRATE
Applicant:Ivax Sub Teva Pharms
Ingredient:tolterodine tartrate
Patents:0
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 0093-0010-06 60 TABLET, FILM COATED in 1 BOTTLE (0093-0010-06)
TOLTERODINE TARTRATE tolterodine tartrate TABLET;ORAL 077006 ANDA Teva Pharmaceuticals USA, Inc. 0093-0018 0093-0018-05 500 TABLET, FILM COATED in 1 BOTTLE (0093-0018-05)

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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