Orange Book product · Generic (ANDA)
DAPAGLIFLOZIN
DAPAGLIFLOZIN
At a glance
Apr 06, 2026
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 06, 2026
2 mo ago
Today
Exclusivity ends · PC
Patent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 4 mo
Pharmaceutical detail
Active ingredient
DAPAGLIFLOZIN
Strength
5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 211156
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DAPAGLIFLOZIN
- 2014FARXIGABrand (NDA)
NDA 202293 · ASTRAZENECA AB
- 2026DAPAGLIFLOZINGeneric (ANDA)
ANDA 211523 · AIZANT
- 2026DAPAGLIFLOZINGeneric (ANDA)
ANDA 211482 · AJANTA PHARMA LTD
- 2026DAPAGLIFLOZINGeneric (ANDA)
ANDA 211560 · ALEMBIC
- 2026DAPAGLIFLOZINGeneric (ANDA)
ANDA 211545 · ALKEM LABS LTD
- 2026DAPAGLIFLOZINGeneric (ANDA)
ANDA 211468 · AUROBINDO PHARMA
- 2026DAPAGLIFLOZINGeneric (ANDA)
ANDA 211470 · BIOCON PHARMA
- 2026DAPAGLIFLOZINGeneric (ANDA)
ANDA 211535 · CIPLA
- 2026DAPAGLIFLOZINGeneric (ANDA)
ANDA 211531 · LUPIN
- 2026DAPAGLIFLOZINGeneric (ANDA)
ANDA 211506 · MACLEODS PHARMS LTD
- 2026DAPAGLIFLOZINGeneric (ANDA)
ANDA 211467 · MICRO LABS
- 2026DAPAGLIFLOZINGeneric (ANDA)
ANDA 211478 · MSN
Marketing exclusivity (1)
- PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 4 mo
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.
