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Active ingredient

Nilotinib

25 finished FDA listings contain Nilotinib as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
NILOTINIB, NILOTINIB HYDROCHLORIDE MONOHYDRATE, NILOTINIB TARTRATE
Dosage forms
Capsule, Tablet, Tablet, Orally Disintegrating
Routes
Oral
Manufacturers / labelers
10
Strengths listed
150 mg/1 · 200 mg/1 · 50 mg/1 · 60 mg/1 · 71 mg/1 · 80 mg/1 · 95 mg/1
Brand names in FDA listings
Cavhanza, Danziten, Tasigna

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 662281

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 022068NOVARTIS2007-10-293
ANDA 203640APOTEX2024-01-053
NDA 219293AZURITY2024-11-072
NDA 218922CIPLA2025-02-193
ANDA 218544MSN2025-11-195
ANDA 209651HETERO LABS LTD V2025-11-192
ANDA 218350DR REDDYS2025-11-193
ANDA 218532TORRENT2025-12-152
NDA 217379CYCLE2026-05-292

Official labeling on DailyMed

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