FDA.reportPublic FDA data

Application 200271

Type
ANDA
Sponsor
ASPEN GLOBAL INC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67457-886Hydroxyprogesterone CaproateHydroxyprogesterone CaproateMylan Institutional LLCANDACurrent
67457-886Hydroxyprogesterone CaproateHydroxyprogesterone CaproateMylan Institutional LLCANDACurrent
67457-886Hydroxyprogesterone CaproateHydroxyprogesterone CaproateMylan Institutional LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18953ORIG2015-10-02
32016ORIG2015-09-16