FDA.reportPublic FDA data

Application 079014

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALFUZOSIN HYDROCHLORIDEALFUZOSIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-5005Alfuzosin HydrochloridealfuzosinMylan Pharmaceuticals Inc.ANDACurrent
43353-746Alfuzosin HydrochloridealfuzosinAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31404ORIG2011-07-20