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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 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: 203016

Tradename:
TOLTERODINE TARTRATE
Applicant:
Torrent Pharms Ltd
Ingredient:
tolterodine tartrate
Patents:0
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details

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
tolterodine tartrate
CAPSULE, EXTENDED RELEASE;ORAL 203016 ANDA Major Pharmaceuticals 0904-6592 0904-6592-04 30 BLISTER PACK in 1 CARTON (0904-6592-04) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK
TOLTERODINE TARTRATE
tolterodine tartrate
CAPSULE, EXTENDED RELEASE;ORAL 203016 ANDA Major Pharmaceuticals 0904-6593 0904-6593-04 30 BLISTER PACK in 1 CARTON (0904-6593-04) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK

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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