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Queensland Health
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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201486

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NDA 201486 describes TOLTERODINE TARTRATE, which is a drug marketed by Mylan Pharms Inc, Teva Pharms Usa, Torrent Pharms Ltd, Apotex Corp, Ivax Sub Teva Pharms, and Macleods Pharms Ltd, and is included in seven NDAs. It is available from eleven 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. Eighteen suppliers are listed for this compound. Additional details are available on the tolterodine tartrate profile page.

Summary for 201486

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 201486

Medical Subject Heading (MeSH) Categories for 201486

Suppliers and Packaging for NDA: 201486

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOLTERODINE TARTRATE 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)
TOLTERODINE TARTRATE 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)

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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Serving leading biopharmaceutical companies globally:

Citi
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Deloitte

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