.

BioPharmaceutical Business Intelligence

  • Identify first generic entrants
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Dow
Deloitte
Novartis
Teva
Healthtrust
Farmers Insurance
Cipla
Colorcon
Harvard Business School
Medtronic

Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020897

« Back to Dashboard

NDA 020897 describes DITROPAN XL, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from five suppliers. Additional details are available on the DITROPAN XL profile page.

The generic ingredient in DITROPAN XL is oxybutynin chloride. There are sixteen drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the oxybutynin chloride profile page.

Summary for 020897

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020897

Suppliers and Packaging for NDA: 020897

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DITROPAN XL oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 020897 NDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7521 0615-7521-39 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7521-39)
DITROPAN XL oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 020897 NDA Patriot Pharmaceuticals, LLC 10147-0761 10147-0761-0 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (10147-0761-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Dec 16, 1998TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Dec 16, 1998TE:ABRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength15MG
Approval Date:Jun 22, 1999TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 020897

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen PharmsDITROPAN XLoxybutynin chlorideTABLET, EXTENDED RELEASE;ORAL020897-002Dec 16, 1998► Subscribe► Subscribe
Janssen PharmsDITROPAN XLoxybutynin chlorideTABLET, EXTENDED RELEASE;ORAL020897-002Dec 16, 1998► Subscribe► Subscribe
Janssen PharmsDITROPAN XLoxybutynin chlorideTABLET, EXTENDED RELEASE;ORAL020897-001Dec 16, 1998► Subscribe► Subscribe
Janssen PharmsDITROPAN XLoxybutynin chlorideTABLET, EXTENDED RELEASE;ORAL020897-002Dec 16, 1998► Subscribe► Subscribe
Janssen PharmsDITROPAN XLoxybutynin chlorideTABLET, EXTENDED RELEASE;ORAL020897-002Dec 16, 1998► Subscribe► Subscribe
Janssen PharmsDITROPAN XLoxybutynin chlorideTABLET, EXTENDED RELEASE;ORAL020897-002Dec 16, 1998► Subscribe► Subscribe
Janssen PharmsDITROPAN XLoxybutynin chlorideTABLET, EXTENDED RELEASE;ORAL020897-001Dec 16, 1998► Subscribe► Subscribe
Janssen PharmsDITROPAN XLoxybutynin chlorideTABLET, EXTENDED RELEASE;ORAL020897-003Jun 22, 1999► Subscribe► Subscribe
Janssen PharmsDITROPAN XLoxybutynin chlorideTABLET, EXTENDED RELEASE;ORAL020897-003Jun 22, 1999► Subscribe► Subscribe
Janssen PharmsDITROPAN XLoxybutynin chlorideTABLET, EXTENDED RELEASE;ORAL020897-001Dec 16, 1998► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.



Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Merck
Cipla
Fish and Richardson
Novartis
Healthtrust
Daiichi Sankyo
US Army
Chubb
Federal Trade Commission

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot