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Generated: June 22, 2017

DrugPatentWatch Database Preview

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, Teva Pharms Usa, Mylan Pharms Inc, and Apotex Corp, and is included in seven NDAs. It is available from ten 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. Nineteen suppliers are listed for this compound. Additional details are available on the tolterodine tartrate profile page.

Summary for NDA: 203016

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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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Serving 500+ biopharmaceutical companies globally:

Deloitte
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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