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Details for New Drug Application (NDA): 077006

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NDA 077006 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 six suppliers. Additional details are available on the TOLTERODINE TARTRATE profile page.

The generic ingredient in TOLTERODINE TARTRATE is tolterodine tartrate. There are twenty-two drug master file entries for this compound. Fifteen 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: 077006

Ivax Sub Teva Pharms
tolterodine tartrate
Therapeutic Class:Genitourinary Agents

Pharmacology for NDA: 077006

Suppliers and Packaging for NDA: 077006

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
tolterodine tartrate
TABLET;ORAL 077006 ANDA Teva Pharmaceuticals USA Inc 0093-0010 0093-0010-05 500 TABLET, FILM COATED in 1 BOTTLE (0093-0010-05)
tolterodine tartrate
TABLET;ORAL 077006 ANDA Teva Pharmaceuticals USA Inc 0093-0010 0093-0010-06 60 TABLET, FILM COATED in 1 BOTTLE (0093-0010-06)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Feb 23, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Feb 23, 2015TE:ABRLD:No

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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.