FDA.reportPublic FDA data

Application 211070

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
55150-310HYDROXYPROGESTERONE CAPROATEHYDROXYPROGESTERONE CAPROATEAuroMedics Pharma LLCANDACurrent
55150-310HYDROXYPROGESTERONE CAPROATEHYDROXYPROGESTERONE CAPROATEAuroMedics Pharma LLCANDACurrent