FDA.reportPublic FDA data

Application 089325

Type
ANDA
Sponsor
QUAD PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TESTOSTERONE ENANTHATETESTOSTERONE ENANTHATEInjectable; Injection200MG/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 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TESTOSTERONE ENANTHATETESTOSTERONE ENANTHATEEugia US LLC82a98132-9d5f-40a5-8c4f-f52f2a5de60e2026-06-12Warnings, Adverse reactionsName fallback
brand name: TESTOSTERONE ENANTHATE
generic name: TESTOSTERONE ENANTHATE
TESTOSTERONE ENANTHATETESTOSTERONE ENANTHATEHikma Pharmaceuticals USA Inc.e89d6458-428c-4256-97a3-f1fa851293c12026-05-08Warnings, Adverse reactionsName fallback
brand name: TESTOSTERONE ENANTHATE
generic name: TESTOSTERONE ENANTHATE
XYOSTEDTESTOSTERONE ENANTHATEAntares Pharma, Inc.8a3d204c-be26-49e0-8599-0ac12a272e812025-07-01Warnings, Adverse reactionsName fallback
generic name: TESTOSTERONE ENANTHATE

Reported adverse events (FAERS/openFDA)#

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