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Last Updated: July 7, 2020

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Details for New Drug Application (NDA): 020771


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NDA 020771 describes DETROL, which is a drug marketed by Pharmacia And Upjohn and is included in two NDAs. It is available from three suppliers. There are three patents protecting this drug and two Paragraph IV challenges. Additional details are available on the DETROL profile page.

The generic ingredient in DETROL is tolterodine tartrate. There are twenty-three drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the tolterodine tartrate profile page.
Summary for 020771
Tradename:DETROL
Applicant:Pharmacia And Upjohn
Ingredient:tolterodine tartrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020771
Medical Subject Heading (MeSH) Categories for 020771
Suppliers and Packaging for NDA: 020771
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DETROL tolterodine tartrate TABLET;ORAL 020771 NDA Pharmacia and Upjohn Company LLC 0009-4541 0009-4541-02 60 TABLET, FILM COATED in 1 BOTTLE (0009-4541-02)
DETROL tolterodine tartrate TABLET;ORAL 020771 NDA Pharmacia and Upjohn Company LLC 0009-4544 0009-4544-02 60 TABLET, FILM COATED in 1 BOTTLE (0009-4544-02)
Paragraph IV (Patent) Challenges for 020771
Tradename Dosage Ingredient NDA Submissiondate
DETROL TABLET;ORAL tolterodine tartrate 020771

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Mar 25, 1998TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Mar 25, 1998TE:ABRLD:Yes

Expired US Patents for NDA 020771

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn DETROL tolterodine tartrate TABLET;ORAL 020771-001 Mar 25, 1998   Start Trial   Start Trial
Pharmacia And Upjohn DETROL tolterodine tartrate TABLET;ORAL 020771-002 Mar 25, 1998   Start Trial   Start Trial
Pharmacia And Upjohn DETROL tolterodine tartrate TABLET;ORAL 020771-002 Mar 25, 1998   Start Trial   Start Trial
Pharmacia And Upjohn DETROL tolterodine tartrate TABLET;ORAL 020771-002 Mar 25, 1998   Start Trial   Start Trial
Pharmacia And Upjohn DETROL tolterodine tartrate TABLET;ORAL 020771-001 Mar 25, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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