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Generated: March 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074868

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NDA 074868 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 074868
Applicant:Wockhardt Bio Ag
Ingredient:oxybutynin chloride
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 074868
Suppliers and Packaging for NDA: 074868
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYBUTYNIN CHLORIDE oxybutynin chloride SYRUP;ORAL 074868 ANDA Atlantic Biologicals Corps 17856-0092 N 17856-0092-1
OXYBUTYNIN CHLORIDE oxybutynin chloride SYRUP;ORAL 074868 ANDA Morton Grove Pharmaceuticals, Inc. 60432-092 N 60432-092-16

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength5MG/5ML
Approval Date:Feb 12, 1997TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
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Cantor Fitzgerald

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