Last Updated: September 24, 2026

Details for New Drug Application (NDA): 200164

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NDA 200164 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, Pharmobedient, Rising, and Unique, and is included in sixteen NDAs. It is available from fourteen suppliers. Additional details are available on the TOLTERODINE TARTRATE profile page.

The generic ingredient in TOLTERODINE TARTRATE is tolterodine tartrate. There is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the tolterodine tartrate profile page.

Summary for 200164

Tradename:	TOLTERODINE TARTRATE
Applicant:	Apotex Corp
Ingredient:	tolterodine tartrate
Patents:	0

Medical Subject Heading (MeSH) Categories for 200164

Muscarinic Antagonists
Urological Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Sep 25, 2012	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Sep 25, 2012	TE:		RLD:	No

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