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Details for New Drug Application (NDA): 203016

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NDA 203016 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 six 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. Fifteen 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: 203016

Torrent Pharms Ltd
tolterodine tartrate
Therapeutic Class:Genitourinary Agents

Pharmacology for NDA: 203016

Suppliers and Packaging for NDA: 203016

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
tolterodine tartrate
CAPSULE, EXTENDED RELEASE;ORAL 203016 ANDA Torrent Pharmaceuticals Limited 13668-189 13668-189-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (13668-189-05)
tolterodine tartrate
CAPSULE, EXTENDED RELEASE;ORAL 203016 ANDA Torrent Pharmaceuticals Limited 13668-189 13668-189-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (13668-189-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength2MG
Approval Date:Aug 11, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength4MG
Approval Date:Aug 11, 2015TE:ABRLD:No

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