FDA.reportPublic FDA data

Application 077334

Type
ANDA
Sponsor
AMPHASTAR PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEDROXYPROGESTERONE ACETATEMEDROXYPROGESTERONE ACETATEINJECTABLE;INJECTION150MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0548-5701Medroxyprogesterone AcetateMedroxyprogesterone acetateAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5701Medroxyprogesterone AcetateMedroxyprogesterone acetateAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5711Medroxyprogesterone AcetateMedroxyprogesterone acetateAmphastar Pharmaceuticals, Inc.ANDACurrent
0548-5711Medroxyprogesterone AcetateMedroxyprogesterone acetateAmphastar Pharmaceuticals, Inc.ANDACurrent
70518-3336Medroxyprogesterone AcetateMedroxyprogesterone acetateREMEDYREPACK INC.ANDACurrent