FDA.reportPublic FDA data

Application 213950

Type
ANDA
Sponsor
AMNEAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ETHINYL ESTRADIOL AND NORELGESTROMINETHINYL ESTRADIOL; NORELGESTROMINFILM, EXTENDED RELEASE;TRANSDERMAL0.035MG/24HR;0.15MG/24HRNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65162-358ZAFEMYNorelgestromin and Ethinly EstradiolAmneal Pharmaceuticals LLCANDACurrent
65162-358ZAFEMYNorelgestromin and Ethinly EstradiolAmneal Pharmaceuticals LLCANDACurrent
69238-1521Norelgestromin and Ethinly EstradiolNorelgestromin and Ethinly EstradiolAmneal Pharmaceuticals NY LLCANDACurrent
69238-1521Norelgestromin and Ethinly EstradiolNorelgestromin and Ethinly EstradiolAmneal Pharmaceuticals NY LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79316ORIG 2024-08-06