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Active ingredient

Deferasirox

96 finished FDA listings contain Deferasirox as their only active ingredient.

FDA NDC Directory

Ingredient names as written by FDA
DEFERASIROX
Dosage forms
Granule, Tablet, Tablet, Film Coated, Tablet, For Suspension
Routes
Oral
Manufacturers / labelers
22
Strengths listed
125 mg/1 · 180 mg/1 · 250 mg/1 · 360 mg/1 · 500 mg/1 · 90 mg/1
Brand names in FDA listings
Deferasirox Oral Granules, Deferasorox, Exjade, Jadenu

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 614373

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 021882NOVARTIS2005-11-023
NDA 206910NOVARTIS PHARMS CORP2015-03-303
ANDA 203560ACTAVIS ELIZABETH2016-01-262
NDA 207968NOVARTIS2017-05-183
ANDA 210060ALEMBIC2019-11-206
ANDA 210519ALKEM LABS LTD2019-11-203
ANDA 210920BIONPHARMA2019-11-203
ANDA 209878MSN2019-11-209
ANDA 210945MSN2019-11-207
ANDA 211383ZYDUS PHARMS2019-11-206
ANDA 211824ALEMBIC2019-11-206
ANDA 209782SUN PHARM2019-11-203
ANDA 210727STEVENS J2019-12-273
ANDA 212995PIRAMAL2019-12-303
ANDA 209433GLENMARK SPECLT2020-01-033
ANDA 210555ALKEM LABS LTD2020-03-303
ANDA 213374ALKEM LABS LTD2020-07-143
ANDA 214559AUCTA2021-03-093
ANDA 214650MSN2021-03-173
ANDA 214341ANNORA PHARMA2021-05-143
ANDA 215026CIPLA2022-02-233
ANDA 216229ANNORA PHARMA2022-09-223
ANDA 207124TEVA PHARMS USA2022-09-233
ANDA 214474AUROBINDO PHARMA LTD2023-10-166
ANDA 215137AUROBINDO PHARMA2025-09-083

Official labeling on DailyMed

Showing the 12 most recent of 32 labels.

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