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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 201486

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NDA 201486 describes TOLTERODINE TARTRATE, which is a drug marketed by Ajanta Pharma Ltd, Aurobindo Pharma Usa, Hetero Labs Ltd Iii, Inventia Hlthcare, Teva Pharms Usa, Torrent, Unichem, Utopic Pharms, Apotex Corp, Hetero Labs Ltd V, Ivax Sub Teva Pharms, Macleods Pharms Ltd, Pharmobedient, Pts Consulting, and Rising, and is included in sixteen NDAs. It is available from fifteen 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:	Aurobindo Pharma Usa
Ingredient:	tolterodine tartrate
Patents:	0

Medical Subject Heading (MeSH) Categories for 201486

Muscarinic Antagonists
Urological Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	2MG
Approval Date:	Oct 31, 2013	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	4MG
Approval Date:	Oct 31, 2013	TE:		RLD:	No

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