FDA.reportPublic FDA data

Application 089331

Type
ANDA
Sponsor
QUAD PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYPROGESTERONE CAPROATEHYDROXYPROGESTERONE CAPROATEInjectable; Injection250MG/MLNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.