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Active ingredient

Dasatinib

102 finished FDA listings contain Dasatinib as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
DASATINIB, DASATINIB ANHYDROUS
Dosage forms
Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
17
Strengths listed
100 mg/1 · 140 mg/1 · 20 mg/1 · 50 mg/1 · 70 mg/1 · 80 mg/1
Brand names in FDA listings
Phyrago, Sprycel

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 475342

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 021986BRISTOL MYERS SQUIBB2006-06-2812
ANDA 202103APOTEX2016-06-104
ANDA 203180APOTEX2021-11-232
NDA 216099HANDA THERAP2023-12-056
ANDA 213383DR REDDYS2025-03-036
ANDA 218719ZYDUS PHARMS2025-03-0312
ANDA 217217BIOCON PHARMA2025-03-0312
ANDA 216547EUGIA PHARMA2025-04-226
ANDA 214350LUPIN2025-08-256
ANDA 211094TEVA PHARMS USA2025-08-2712
ANDA 216261ALEMBIC2025-11-0618
ANDA 219579MSN2026-09-116

Official labeling on DailyMed

Showing the 12 most recent of 15 labels.

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