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Serving leading biopharmaceutical companies globally:

Citi
Covington
Boehringer Ingelheim
US Army
McKesson
Chubb
Mallinckrodt
Deloitte
Daiichi Sankyo
McKinsey

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076702

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NDA 076702 describes OXYBUTYNIN CHLORIDE, which is a drug marketed by Apotex Inc, Mikart, Pharm Assoc, Silarx, Vintage Pharms, Wockhardt, Accord Hlthcare, Amneal Pharms, Impax Pharms, Mylan, Mylan Pharms Inc, Osmotica Pharm Us, Unique Pharm Labs, Zydus Pharms Usa Inc, Novitium Pharma, Quantum Pharmics, Teva Pharms Usa, Upsher-smith Labs, Usl Pharma, and Watson Labs, and is included in twenty-one NDAs. It is available from forty-eight suppliers. Additional details are available on the OXYBUTYNIN CHLORIDE profile page.

The generic ingredient in OXYBUTYNIN CHLORIDE is oxybutynin chloride. There are sixteen drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the oxybutynin chloride profile page.
Summary for 076702
Tradename:OXYBUTYNIN CHLORIDE
Applicant:Mylan
Ingredient:oxybutynin chloride
Patents:0
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076702
Suppliers and Packaging for NDA: 076702
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 076702 ANDA Mylan Pharmaceuticals Inc. 0378-6605 0378-6605-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-6605-01)
OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 076702 ANDA Mylan Pharmaceuticals Inc. 0378-6605 0378-6605-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-6605-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Nov 9, 2006TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Moodys
US Department of Justice
Chubb
Novartis
Queensland Health
Healthtrust
Accenture
UBS
Julphar

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