Application 214293

Type
ANDA
Sponsor
AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESTRADIOL AND PROGESTERONEESTRADIOL; PROGESTERONECAPSULE;ORAL1MG;100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69238-1690Estradiol and ProgesteroneEstradiol and ProgesteroneAmneal Pharmaceuticals NY LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71881ORIG2022-08-25
69662ORIG2021-12-20