FDA.reportPublic FDA data

Application 207769

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDEDUTASTERIDE; TAMSULOSIN HYDROCHLORIDECAPSULE;ORAL0.5MG;0.4MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-640Dutasteride and tamsulosin hydrochlorideDutasteride and tamsulosin hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-640Dutasteride and tamsulosin hydrochlorideDutasteride and tamsulosin hydrochlorideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-640Dutasteride and tamsulosin hydrochlorideDutasteride and tamsulosin hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-640Dutasteride and tamsulosin hydrochlorideDutasteride and tamsulosin hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1356Dutasteride and tamsulosin hydrochlorideDutasteride and tamsulosin hydrochlorideZydus Lifesciences LimitedANDACurrent
70771-1356Dutasteride and tamsulosin hydrochlorideDutasteride and tamsulosin hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1356Dutasteride and tamsulosin hydrochlorideDutasteride and tamsulosin hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1356Dutasteride and tamsulosin hydrochlorideDutasteride and tamsulosin hydrochlorideCadila Healthcare LimitedANDACurrent