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Active ingredient

Bortezomib

33 finished FDA listings contain Bortezomib as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
BORTEZOMIB
Dosage forms
Injection, Injection, Powder, Lyophilized, For Solution
Routes
Intravenous, Subcutaneous
Manufacturers / labelers
26
Strengths listed
1 mg/1 · 1 mg/ml · 2.5 mg/1 · 3.5 mg/1 · 3.5 mg/1.4ml · 3.5 mg/3.5ml
Brand names in FDA listings
Boruzu, Velcade

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 358258

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
NDA 021602TAKEDA PHARMS USA2003-05-131
ANDA 209659FRESENIUS KABI USA2022-05-021
ANDA 208392PHARMASCIENCE INC2022-05-021
NDA 209191HOSPIRA2022-05-022
ANDA 210204ZYDUS PHARMS2022-05-022
ANDA 205533APOTEX2022-05-021
ANDA 210824QILU PHARM HAINAN2022-05-023
ANDA 212825EUGIA PHARMA2022-05-022
ANDA 215011JIANGSU HANSOH PHARM2022-07-261
ANDA 209622MSN2022-07-263
ANDA 202963DR REDDYS2022-07-262
ANDA 212958MEITHEAL2022-07-262
ANDA 208460HOSPIRA2022-07-261
NDA 215331MAIA PHARMS INC2022-07-272
ANDA 211898RELIANCE LIFE SCI2022-10-112
ANDA 212204HETERO LABS LTD VI2024-05-031
NDA 212782SHILPA2024-08-262
ANDA 216528SHUANGCHENG2025-12-172
ANDA 219167GLAND2026-01-062

Official labeling on DailyMed

Showing the 12 most recent of 30 labels.

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