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Details for New Drug Application (NDA): 021228

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NDA 021228 describes DETROL LA, which is a drug marketed by Pharmacia And Upjohn and is included in one NDA. It is available from eight suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the DETROL LA profile page.

The generic ingredient in DETROL LA 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: 021228

Tradename:
DETROL LA
Applicant:
Pharmacia And Upjohn
Ingredient:
tolterodine tartrate
Patents:3
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021228

Suppliers and Packaging for NDA: 021228

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DETROL LA
tolterodine tartrate
CAPSULE, EXTENDED RELEASE;ORAL 021228 NDA Pharmacia and Upjohn Company 0009-5190 0009-5190-01 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0009-5190-01)
DETROL LA
tolterodine tartrate
CAPSULE, EXTENDED RELEASE;ORAL 021228 NDA Pharmacia and Upjohn Company 0009-5190 0009-5190-02 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0009-5190-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength2MG
Approval Date:Dec 22, 2000TE:ABRLD:No
Patent:6,630,162*PEDPatent Expiration:May 11, 2020Product Flag?Substance Flag?Delist Request?Y
Patent:6,770,295*PEDPatent Expiration:Feb 26, 2020Product Flag?Substance Flag?Delist Request?Y
Patent:6,911,217*PEDPatent Expiration:May 11, 2020Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021228

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn
DETROL LA
tolterodine tartrate
CAPSULE, EXTENDED RELEASE;ORAL021228-002Dec 22, 20005,382,600*PED► subscribe
Pharmacia And Upjohn
DETROL LA
tolterodine tartrate
CAPSULE, EXTENDED RELEASE;ORAL021228-002Dec 22, 20005,559,269*PED► subscribe
Pharmacia And Upjohn
DETROL LA
tolterodine tartrate
CAPSULE, EXTENDED RELEASE;ORAL021228-001Dec 22, 20005,382,600*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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