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Serving leading biopharmaceutical companies globally:

Queensland Health
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Fish and Richardson
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Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207138

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NDA 207138 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 fifty 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-four suppliers are listed for this compound. Additional details are available on the oxybutynin chloride profile page.
Summary for 207138
Tradename:OXYBUTYNIN CHLORIDE
Applicant:Accord Hlthcare
Ingredient:oxybutynin chloride
Patents:0
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 207138
Suppliers and Packaging for NDA: 207138
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 207138 ANDA Accord Healthcare, Inc. 16729-317 N 16729-317-16
OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 207138 ANDA Accord Healthcare, Inc. 16729-317 N 16729-317-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Feb 29, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Feb 29, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength15MG
Approval Date:Feb 29, 2016TE:ABRLD:No

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