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Active ingredient

Denosumab

22 finished FDA listings contain Denosumab as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
DENOSUMAB, DENOSUMAB-DSSB
Dosage forms
Injection, Injection, Solution
Routes
Subcutaneous
Manufacturers / labelers
10
Strengths listed
120 mg/1.7ml · 60 mg/ml · 70 mg/ml
Brand names in FDA listings
Aukelso, Bildyos, Bilprevda, Bomyntra, Boncresa, Bosaya, Conexxence, Enoby, Jubbonti, Jubereq, Osenvelt, Ospomyv, Osvyrti, Oziltus, Prolia, Stoboclo, Wyost, Xgeva, Xtrenbo

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 993449

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
BLA 125320AMGEN2010-06-012
BLA 761362SANDOZ INC2024-03-052
BLA 761392SAMSUNG BIOEPIS CO LTD2025-02-131
BLA 761404CELLTRION INC2025-02-284
BLA 761398FRESENIUS KABI USA LLC2025-03-253
BLA 761444SHANGHAI HENLIUS BIOTECH2025-08-292
BLA 761436BIOCON BIOLOGICS INC2025-09-162
BLA 761439HIKMA PHARMACEUTICALS USA INC2025-09-262
BLA 761424ACCORD BIOPHARMA INC.2025-10-292
BLA 761456AMNEAL PHARMS LLC2025-12-191
BLA 761457AMNEAL PHARMS LLC2025-12-191

Official labeling on DailyMed

Showing the 12 most recent of 21 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.