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Last Updated: May 15, 2021

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Details for New Drug Application (NDA): 075137

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NDA 075137 describes OXYBUTYNIN CHLORIDE, which is a drug marketed by Par Pharm Inc, Anda Repository, Lannett Co Inc, Pharm Assoc, Wockhardt Bio Ag, Accord Hlthcare, Ajanta Pharma Ltd, Amneal Pharms, Bionpharma Inc, Impax Pharms, Mylan, Mylan Pharms Inc, Osmotica Pharm Us, Rubicon, Unique Pharm Labs, Zydus Pharms, Abhai Llc, Appco, Emcure Pharms Ltd, Eywa, Leading Pharma Llc, Novast Labs, Novitium Pharma, Quantum Pharmics, Strides Pharma, Teva Pharms Usa, Tulex Pharms Inc, Upsher Smith Labs, Usl Pharma, Vintage Pharms, and Watson Labs, and is included in thirty-three NDAs. It is available from forty 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. Forty-two suppliers are listed for this compound. Additional details are available on the oxybutynin chloride profile page.
Summary for 075137
Tradename:OXYBUTYNIN CHLORIDE
Applicant:Pharm Assoc
Ingredient:oxybutynin chloride
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength5MG/5ML
Approval Date:Dec 18, 1998TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

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