Orange Book product · Generic (ANDA)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
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; METFORMIN HYDROCHLORIDE
Strength
5MG;1GM
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
ANDA 211491
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
- 2017XIGDUO XRBrand (NDA)
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ANDA 211563 · ALKEM LABS LTD
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ANDA 211489 · AUROBINDO PHARMA
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ANDA 211595 · CIPLA
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ANDA 211536 · CIPLA LTD
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ANDA 211579 · LUPIN
- 2026DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 211559 · MACLEODS PHARMS LTD
- 2026DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 211466 · MICRO LABS
- 2026DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 211479 · MSN
- 2026DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 211583 · TEVA PHARMS USA INC
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.
