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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 074625


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NDA 074625 describes OXYBUTYNIN CHLORIDE, which is a drug marketed by Chartwell Rx, Lannett Co Inc, Pharm Assoc, Pharmobedient Cnsltg, Accord Hlthcare, Ajanta Pharma Ltd, Amneal Pharms, Bionpharma, Impax Pharms, Mylan, Mylan Pharms Inc, Osmotica Pharm Us, Rubicon, Unique, Zydus Pharms, Abhai Llc, Avet Lifesciences, Beximco Pharms Usa, Eywa, Leading, Novast Labs, Novitium Pharma, Quantum Pharmics, Rising, Strides Pharma, Teva Pharms Usa, Tulex Pharms Inc, Upsher Smith Labs, Usl Pharma, and Watson Labs, and is included in thirty-four NDAs. It is available from thirty-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. Forty suppliers are listed for this compound. Additional details are available on the oxybutynin chloride profile page.
Summary for 074625
Tradename:OXYBUTYNIN CHLORIDE
Applicant:Upsher Smith Labs
Ingredient:oxybutynin chloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 074625
Suppliers and Packaging for NDA: 074625
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET;ORAL 074625 ANDA Upsher-Smith Laboratories, LLC 0832-0038 0832-0038-00 100 TABLET in 1 BOTTLE (0832-0038-00)
OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET;ORAL 074625 ANDA Upsher-Smith Laboratories, LLC 0832-0038 0832-0038-01 100 BLISTER PACK in 1 CARTON (0832-0038-01) / 1 TABLET in 1 BLISTER PACK (0832-0038-89)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jul 31, 1996TE:ABRLD:No

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