FDA.reportPublic FDA data

Application 076745

Type
ANDA
Sponsor
IMPAX PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDETABLET, EXTENDED RELEASE;ORAL15MGNoNo
002OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDETABLET, EXTENDED RELEASE;ORAL5MGNoNo
003OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDETABLET, EXTENDED RELEASE;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-5206OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDETEVA Pharmaceuticals USA ANDACurrent
0093-5206OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDETEVA Pharmaceuticals USA IncANDACurrent
0093-5207OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDETEVA Pharmaceuticals USA ANDACurrent
0093-5207OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDETEVA Pharmaceuticals USA IncANDACurrent
0093-5208OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDETEVA Pharmaceuticals USA ANDACurrent
0093-5208OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDETEVA Pharmaceuticals USA IncANDACurrent
0179-0187OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDEKAISER FOUNDATION HOSPITALSANDACurrent
63629-5484OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDEBryant Ranch PrepackANDACurrent
63629-6355OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDEBryant Ranch PrepackANDACurrent
66336-604OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDEDispensing Solutions, Inc.ANDACurrent
68151-3646OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDECarilion Materials ManagementANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22583ORIG2013-08-09
8954ORIG2006-11-14