Orange Book product · Generic (ANDA)
DASATINIB
DASATINIB
At a glance
Nov 06, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 06, 2025
8 mo ago
Today
Pharmaceutical detail
Active ingredient
DASATINIB
Strength
20MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 216261
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DASATINIB
- 2023PHYRAGOBrand (NDA)
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- 2006SPRYCELBrand (NDA)
NDA 021986 · BRISTOL MYERS SQUIBB
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ANDA 211094 · TEVA PHARMS USA
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ANDA 214350 · LUPIN
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ANDA 216547 · EUGIA PHARMA
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ANDA 217217 · BIOCON PHARMA
- 2025DASATINIBGeneric (ANDA)
ANDA 213383 · DR REDDYS
- 2025DASATINIBGeneric (ANDA)
ANDA 218719 · ZYDUS PHARMS
- 2021DASATINIBGeneric (ANDA)
ANDA 203180 · APOTEX
- 2016DASATINIBGeneric (ANDA)
ANDA 202103 · APOTEX
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
