FDA.reportPublic FDA data

Application 076644

Type
ANDA
Sponsor
MYLAN PHARMS INC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-6610Oxybutynin Chlorideoxybutynin chlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6610Oxybutynin Chlorideoxybutynin chlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6610Oxybutynin Chlorideoxybutynin chlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6615Oxybutynin Chlorideoxybutynin chlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6615Oxybutynin Chlorideoxybutynin chlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6615Oxybutynin Chlorideoxybutynin chlorideMylan Pharmaceuticals Inc.ANDACurrent
0615-7520Oxybutynin Chlorideoxybutynin chlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7520Oxybutynin Chlorideoxybutynin chlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
51079-723Oxybutynin Chlorideoxybutynin chlorideMylan Institutional Inc.ANDACurrent
51079-723Oxybutynin Chlorideoxybutynin chlorideMylan Institutional Inc.ANDACurrent
55154-6298Oxybutynin Chlorideoxybutynin chlorideCardinal HealthANDACurrent
70518-0965Oxybutynin Chlorideoxybutynin chlorideREMEDYREPACK INC.ANDACurrent
70518-0965Oxybutynin Chlorideoxybutynin chlorideREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43093ORIG2013-08-09
31150ORIG2006-11-14