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

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyprogesterone CaproateHYDROXYPROGESTERONE CAPROATEEugia US LLC687bcf42-f437-42c7-8909-a91f621f55df2026-06-12Warnings, Adverse reactionsName fallback
brand name: Hydroxyprogesterone Caproate
generic name: HYDROXYPROGESTERONE CAPROATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55150-310HYDROXYPROGESTERONE CAPROATEHYDROXYPROGESTERONE CAPROATEAuroMedics Pharma LLCANDACurrent
55150-310HYDROXYPROGESTERONE CAPROATEHYDROXYPROGESTERONE CAPROATEAuroMedics Pharma LLCANDACurrent