FDA.reportPublic FDA data

Application 207724

Type
ANDA
Sponsor
AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROGESTERONEPROGESTERONECAPSULE;ORAL100MGNoNo
002PROGESTERONEPROGESTERONECAPSULE;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4656ProgesteroneProgesteroneA-S Medication SolutionsANDACurrent
50090-4656ProgesteroneProgesteroneA-S Medication SolutionsANDACurrent
65162-807ProgesteroneProgesteroneAmneal Pharmaceuticals LLCANDACurrent
65162-807ProgesteroneProgesteroneAmneal Pharmaceuticals LLCANDACurrent
65162-807ProgesteroneProgesteroneAmneal Pharmaceuticals LLCANDACurrent
65162-807ProgesteroneProgesteroneAmneal Pharmaceuticals LLCANDACurrent
65162-808ProgesteroneProgesteroneAmneal Pharmaceuticals LLCANDACurrent
65162-808ProgesteroneProgesteroneAmneal Pharmaceuticals LLCANDACurrent
65162-808ProgesteroneProgesteroneAmneal Pharmaceuticals LLCANDACurrent
65162-808ProgesteroneProgesteroneAmneal Pharmaceuticals LLCANDACurrent
71335-1430ProgesteroneProgesteroneBryant Ranch PrepackANDACurrent
71335-1430ProgesteroneProgesteroneBryant Ranch PrepackANDACurrent
71335-1432ProgesteroneProgesteroneBryant Ranch PrepackANDACurrent
71335-1432ProgesteroneProgesteroneBryant Ranch PrepackANDACurrent
76420-058ProgesteroneProgesteroneAsclemed USA, Inc.ANDACurrent
76420-058ProgesteroneProgesteroneAsclemed USA, Inc.ANDACurrent
76420-059ProgesteroneProgesteroneAsclemed USA, Inc.ANDACurrent
76420-059ProgesteroneProgesteroneAsclemed USA, Inc.ANDACurrent