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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 five 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. Sixteen 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: 020771

Tradename:
DETROL
Applicant:
Pharmacia And Upjohn
Ingredient:
tolterodine tartrate
Patents:0
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 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 0009-4541 0009-4541-01 140 BLISTER PACK in 1 CARTON (0009-4541-01) > 1 TABLET, FILM COATED in 1 BLISTER PACK
DETROL
tolterodine tartrate
TABLET;ORAL 020771 NDA Pharmacia and Upjohn Company 0009-4541 0009-4541-02 60 TABLET, FILM COATED in 1 BOTTLE (0009-4541-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Mar 25, 1998TE:ABRLD:No

Summary for product number 002

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

Expired Orange Book Patents for NDA: 020771

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn
DETROL
tolterodine tartrate
TABLET;ORAL020771-001Mar 25, 19985,382,600*PED► subscribe
Pharmacia And Upjohn
DETROL
tolterodine tartrate
TABLET;ORAL020771-002Mar 25, 19985,550,269*PED► subscribe
Pharmacia And Upjohn
DETROL
tolterodine tartrate
TABLET;ORAL020771-002Mar 25, 19985,559,269*PED► subscribe
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