Application 210618

Type
ANDA
Sponsor
SLAYBACK PHARMA LLC

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
71225-104HYDROXYPROGESTERONE CAPROATEHYDROXYPROGESTERONE CAPROATESlayback Pharma LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57276ORIG2019-01-18