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Last Updated: November 30, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204397


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NDA 204397 describes TOLTERODINE TARTRATE, which is a drug marketed by Ajanta Pharma Ltd, Amta, Hetero Labs Ltd Iii, Inventia Hlthcare, Mylan, Teva Pharms Usa, Torrent, Apotex Corp, Athem, Hetero Labs Ltd V, Ivax Sub Teva Pharms, Macleods Pharms Ltd, Mylan Pharms Inc, Unichem, and Unique Pharm Labs, and is included in fifteen 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 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 204397
Tradename:TOLTERODINE TARTRATE
Applicant:Hetero Labs Ltd V
Ingredient:tolterodine tartrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204397
Medical Subject Heading (MeSH) Categories for 204397
Suppliers and Packaging for NDA: 204397
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOLTERODINE TARTRATE tolterodine tartrate TABLET;ORAL 204397 ANDA Camber Pharmaceuticals, Inc. 31722-805 31722-805-01 10 BLISTER PACK in 1 CARTON (31722-805-01) > 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-805-31)
TOLTERODINE TARTRATE tolterodine tartrate TABLET;ORAL 204397 ANDA Camber Pharmaceuticals, Inc. 31722-805 31722-805-02 10 BLISTER PACK in 1 CARTON (31722-805-02) > 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-805-32)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Aug 2, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Aug 2, 2021TE:ABRLD:No

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