FDA.reportPublic FDA data

Application 207742

Type
ANDA
Sponsor
AM REGENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TESTOSTERONE CYPIONATETESTOSTERONE CYPIONATEINJECTABLE;INJECTION200MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0517-1830Testosterone CypionateTestosterone CypionateAmerican Regent, Inc.ANDACurrent
0517-1830Testosterone CypionateTestosterone CypionateAmerican Regent, Inc.ANDACurrent
47781-910testosterone cypionatetestosterone cypionateAlvogen Inc.ANDACurrent
47781-911testosterone cypionatetestosterone cypionateAlvogen Inc.ANDACurrent
64980-467Testosterone CypionateTestosterone CypionateRising Pharmaceuticals, IANDACurrent
64980-467Testosterone CypionateTestosterone CypionateRising Pharmaceuticals, Inc.ANDACurrent
64980-467Testosterone CypionateTestosterone CypionateRising Pharmaceuticals, Inc.ANDACurrent