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Details for New Drug Application (NDA): 203409

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NDA 203409 describes TOLTERODINE TARTRATE, which is a drug marketed by Ivax Sub Teva Pharms, Macleods Pharms Ltd, Torrent Pharms Ltd, Mylan Pharms Inc, and Apotex Corp, and is included in six NDAs. It is available from seven 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. There are four tentative approvals for this compound. Additional details are available on the tolterodine tartrate profile page.

Summary for NDA: 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

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 33342-097-09 60 TABLET, FILM COATED in 1 BOTTLE (33342-097-09)
TOLTERODINE TARTRATE
tolterodine tartrate
TABLET;ORAL 203409 ANDA Macleods Pharmaceuticals Limited 33342-097 33342-097-12 10 BLISTER PACK in 1 CARTON (33342-097-12) > 10 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

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

Summary for product number 002

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


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