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Serving leading biopharmaceutical companies globally:

Citi
Fuji
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Julphar
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Cerilliant
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US Army
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Generated: December 14, 2017

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, 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-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:1
Applicant:1
Ingredient:1
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 0904-6570-06 50 BLISTER PACK in 1 CARTON (0904-6570-06) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 204010 ANDA Major Pharmaceuticals 0904-6570 0904-6570-61 100 BLISTER PACK in 1 CARTON (0904-6570-61) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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Serving leading biopharmaceutical companies globally:

Colorcon
Dow
Queensland Health
US Army
McKesson
Fish and Richardson
Cantor Fitzgerald
Express Scripts
Citi
Daiichi Sankyo

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