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Serving hundreds of leading biopharmaceutical companies globally:

UBS
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Baxter
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Moodys
AstraZeneca
Citi
Johnson and Johnson

Generated: April 20, 2018

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 Hetero Labs Ltd Iii, Mylan Pharms Inc, Teva Pharms Usa, Torrent Pharms Ltd, Apotex Corp, Ivax Sub Teva Pharms, and Macleods Pharms Ltd, and is included in eight NDAs. It is available from thirteen 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:TOLTERODINE TARTRATE
Applicant:Mylan Pharms Inc
Ingredient:tolterodine tartrate
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 N 0378-3402-05
TOLTERODINE TARTRATE tolterodine tartrate CAPSULE, EXTENDED RELEASE;ORAL 201486 ANDA Mylan Pharmaceuticals Inc. 0378-3402 N 0378-3402-93

Profile for product number 001

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

Profile 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 hundreds of leading biopharmaceutical companies globally:

Dow
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Farmers Insurance
Federal Trade Commission
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Cantor Fitzgerald
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