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Last Updated: August 11, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206121

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NDA 206121 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, Unique Pharm Labs, Zydus Pharms, Abhai Llc, Arise, Athem, Emcure Pharms Ltd, Leading Pharma Llc, Novast Labs, Novitium Pharma, Quantum Pharmics, Teva Pharms Usa, Tulex Pharms Inc, Upsher Smith Labs, Usl Pharma, Vintage Pharms, and Watson Labs, and is included in thirty-one NDAs. It is available from forty-two 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-four suppliers are listed for this compound. Additional details are available on the oxybutynin chloride profile page.
Summary for 206121
Tradename:OXYBUTYNIN CHLORIDE
Applicant:Unique Pharm Labs
Ingredient:oxybutynin chloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206121
Suppliers and Packaging for NDA: 206121
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 206121 ANDA Rising Pharmaceuticals, Inc. 64980-209 64980-209-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-209-01)
OXYBUTYNIN CHLORIDE oxybutynin chloride TABLET, EXTENDED RELEASE;ORAL 206121 ANDA Rising Pharmaceuticals, Inc. 64980-210 64980-210-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (64980-210-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG
Approval Date:May 27, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:May 27, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength15MG
Approval Date:May 27, 2016TE:ABRLD:No

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