FDA.reportPublic FDA data

Application 211293

Type
ANDA
Sponsor
AMNEAL PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESTRADIOLESTRADIOLFILM, EXTENDED RELEASE;TRANSDERMAL0.025MG/24HRNoNo
002ESTRADIOLESTRADIOLFILM, EXTENDED RELEASE;TRANSDERMAL0.0375MG/24HRNoNo
003ESTRADIOLESTRADIOLFILM, EXTENDED RELEASE;TRANSDERMAL0.05MG/24HRNoNo
004ESTRADIOLESTRADIOLFILM, EXTENDED RELEASE;TRANSDERMAL0.075MG/24HRNoNo
005ESTRADIOLESTRADIOLFILM, EXTENDED RELEASE;TRANSDERMAL0.1MG/24HRNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65162-989DOTTIEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-989DOTTIEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-989DOTTIEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-992DOTTIEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-992DOTTIEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-992DOTTIEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-993DOTTIEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-993DOTTIEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-993DOTTIEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-995DOTTIEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-995DOTTIEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-995DOTTIEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-997DOTTIEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-997DOTTIEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-997DOTTIEstradiolAmneal Pharmaceuticals LLCANDACurrent
69238-1629EstradiolEstradiolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1629EstradiolEstradiolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1629EstradiolEstradiolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1629EstradiolEstradiolAmneal Pharmaceuticals LLCANDACurrent
69238-1630EstradiolEstradiolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1630EstradiolEstradiolAmneal Pharmaceuticals LLCANDACurrent
69238-1630EstradiolEstradiolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1630EstradiolEstradiolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1631EstradiolEstradiolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1631EstradiolEstradiolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1631EstradiolEstradiolAmneal Pharmaceuticals LLCANDACurrent
69238-1631EstradiolEstradiolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1632EstradiolEstradiolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1632EstradiolEstradiolAmneal Pharmaceuticals LLCANDACurrent
69238-1632EstradiolEstradiolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1632EstradiolEstradiolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1633EstradiolEstradiolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1633EstradiolEstradiolAmneal Pharmaceuticals LLCANDACurrent
69238-1633EstradiolEstradiolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1633EstradiolEstradiolAmneal Pharmaceuticals NY LLCANDACurrent