FDA.reportPublic FDA data

Application 211396

Type
ANDA
Sponsor
AMNEAL PHARMS

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
65162-126LYLLANAEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-126LYLLANAEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-126LYLLANAEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-126LYLLANAEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-126LYLLANAEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-148LYLLANAEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-148LYLLANAEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-148LYLLANAEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-148LYLLANAEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-148LYLLANAEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-149LYLLANAEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-149LYLLANAEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-149LYLLANAEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-149LYLLANAEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-149LYLLANAEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-150LYLLANAEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-150LYLLANAEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-150LYLLANAEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-150LYLLANAEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-150LYLLANAEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-228LYLLANAEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-228LYLLANAEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-228LYLLANAEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-228LYLLANAEstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-228LYLLANAEstradiolAmneal Pharmaceuticals LLCANDACurrent
69238-1293EstradiolEstradiolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1293EstradiolEstradiolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1294EstradiolEstradiolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1294EstradiolEstradiolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1295EstradiolEstradiolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1295EstradiolEstradiolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1296EstradiolEstradiolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1296EstradiolEstradiolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1447EstradiolEstradiolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1447EstradiolEstradiolAmneal Pharmaceuticals NY LLCANDACurrent