FDA.reportPublic FDA data

Application 090408

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TAMSULOSIN HYDROCHLORIDETAMSULOSIN HYDROCHLORIDECAPSULE;ORAL0.4MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-2500Tamsulosin Hydrochloridetamsulosin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0615-7607Tamsulosin Hydrochloridetamsulosin hydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
43353-703Tamsulosin Hydrochloridetamsulosin hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
51079-294Tamsulosin Hydrochloridetamsulosin hydrochlorideMylan Institutional Inc.ANDACurrent
55154-5359Tamsulosin Hydrochloridetamsulosin hydrochlorideCardinal HealthANDACurrent
55154-5359Tamsulosin Hydrochloridetamsulosin hydrochlorideCardinal HealthANDACurrent