FDA.reportPublic FDA data

Application 205256

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESTRADIOLESTRADIOLTABLET;VAGINAL10MCGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-962YuvafemEstradiolAvKARE, Inc.ANDACurrent
42291-962YuvafemEstradiolAvKAREANDACurrent
42291-962YuvafemEstradiolAvKAREANDACurrent
53746-226EstradiolEstradiolAmneal Pharmaceuticals of New York LLCANDACurrent
53746-226EstradiolEstradiolAmneal Pharmaceuticals of New York LLCANDACurrent
53746-226EstradiolEstradiolAmneal Pharmaceuticals of New York LLCANDACurrent
53746-226EstradiolEstradiolAmneal Pharmaceuticals of New York LLCANDACurrent
53746-226EstradiolEstradiolAmneal Pharmaceuticals of New York LLCANDACurrent
65162-226YUVAFEMEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-226YUVAFEMEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-226YUVAFEMEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-226YUVAFEMEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-226YUVAFEMEstradiolAmneal Pharmaceuticals LLCANDACurrent