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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
US Army
Johnson and Johnson
Queensland Health
Deloitte
Accenture
Daiichi Sankyo
Farmers Insurance
Moodys

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078503

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NDA 078503 describes OXYBUTYNIN CHLORIDE, which is a drug marketed by Apotex Inc, Mikart, Pharm Assoc, Silarx, Vintage Pharms, Wockhardt Bio Ag, Accord Hlthcare, Amneal Pharms, Impax Pharms, Mylan, Mylan Pharms Inc, Osmotica Pharm Us, Unique Pharm Labs, Zydus Pharms Usa Inc, Abhai Llc, Appco Pharma Llc, Novitium Pharma, Quantum Pharmics, Teva Pharms Usa, Upsher-smith Labs, Usl Pharma, and Watson Labs, and is included in twenty-three NDAs. It is available from forty-nine 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-three suppliers are listed for this compound. Additional details are available on the oxybutynin chloride profile page.
Summary for 078503
Tradename:OXYBUTYNIN CHLORIDE
Applicant:Osmotica Pharm Us
Ingredient:oxybutynin chloride
Patents:0
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078503
Suppliers and Packaging for NDA: 078503
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 078503 ANDA Lake Erie Medical DBA Quality Care Products LLC 35356-991 N 35356-991-30
OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 078503 ANDA Lake Erie Medical DBA Quality Care Products LLC 35356-991 N 35356-991-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Feb 4, 2009TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Feb 4, 2009TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength15MG
Approval Date:Feb 4, 2009TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
US Army
Fish and Richardson
Citi
McKesson
Covington
Johnson and Johnson
Fuji
Healthtrust

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