Application 211142

Type
ANDA
Sponsor
EUGIA PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYPROGESTERONE CAPROATEHYDROXYPROGESTERONE CAPROATESOLUTION;INTRAMUSCULAR1250MG/5ML (250MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55150-311Hydroxyprogesterone CaproateHydroxyprogesterone CaproateAuroMedics Pharma LLCANDACurrent
55150-311Hydroxyprogesterone CaproateHydroxyprogesterone CaproateAuroMedics Pharma LLCANDACurrent
55150-311Hydroxyprogesterone CaproateHydroxyprogesterone CaproateAuroMedics Pharma LLCANDACurrent
55150-311Hydroxyprogesterone CaproateHydroxyprogesterone CaproateAuroMedics Pharma LLCANDACurrent