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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204010

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NDA 204010 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 204010
Tradename:OXYBUTYNIN CHLORIDE
Applicant:Amneal Pharms
Ingredient:oxybutynin chloride
Patents:0
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 204010
Suppliers and Packaging for NDA: 204010
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 204010 ANDA Major Pharmaceuticals 0904-6570 N 0904-6570-61
OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 204010 ANDA Major Pharmaceuticals 0904-6570 N 0904-6570-06

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Nov 23, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Nov 23, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength15MG
Approval Date:Nov 23, 2015TE:ABRLD:No

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