Application 211777

Type
ANDA
Sponsor
ASPEN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYPROGESTERONE CAPROATEHYDROXYPROGESTERONE CAPROATESOLUTION;INTRAMUSCULAR250MG/ML (250MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67457-967Hydroxyprogesterone CaproateHydroxyprogesterone CaproateMylan Institutional LLCANDACurrent
67457-967Hydroxyprogesterone CaproateHydroxyprogesterone CaproateMylan Institutional LLCANDACurrent
73301-001Hydroxyprogesterone CaproateHydroxyprogesterone CaproateLSNE-LEON SLUANDACurrent
73301-001Hydroxyprogesterone CaproateHydroxyprogesterone CaproateLSNE, IncANDACurrent