FDA.reportPublic FDA data

Application 076702

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDETABLET, EXTENDED RELEASE;ORAL5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-6605Oxybutynin Chlorideoxybutynin chlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6605Oxybutynin Chlorideoxybutynin chlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6605Oxybutynin Chlorideoxybutynin chlorideMylan Pharmaceuticals Inc.ANDACurrent
0615-7519Oxybutynin Chlorideoxybutynin chlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7519Oxybutynin Chlorideoxybutynin chlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
51079-722Oxybutynin Chlorideoxybutynin chlorideMylan Institutional Inc.ANDACurrent
69189-6605Oxybutynin Chlorideoxybutynin chlorideAvera McKennan HospitalANDACurrent
70518-1205Oxybutynin Chlorideoxybutynin chlorideREMEDYREPACK INC.ANDACurrent
70518-1205Oxybutynin Chlorideoxybutynin chlorideREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22581ORIG2013-08-07
31155ORIG2006-11-14