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Details for New Drug Application (NDA): 201486

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NDA 201486 describes TOLTERODINE TARTRATE, which is a drug marketed by Ivax Sub Teva Pharms, Macleods Pharms Ltd, Torrent Pharms Ltd, Teva Pharms Usa, Mylan Pharms Inc, and Apotex Corp, and is included in seven 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: 201486

Mylan Pharms Inc
tolterodine tartrate
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 201486

Suppliers and Packaging for NDA: 201486

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
tolterodine tartrate
CAPSULE, EXTENDED RELEASE;ORAL 201486 ANDA Mylan Pharmaceuticals Inc. 0378-3402 0378-3402-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-3402-05)
tolterodine tartrate
CAPSULE, EXTENDED RELEASE;ORAL 201486 ANDA Mylan Pharmaceuticals Inc. 0378-3402 0378-3402-93 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-3402-93)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength2MG
Approval Date:Oct 31, 2013TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength4MG
Approval Date:Oct 31, 2013TE:ABRLD:No

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