Orange Book product · Generic (ANDA)
DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE
DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
Generic (ANDA)ANDA 211533TE ABRX MSN
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
Pharmaceutical detail
Active ingredient
DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
Strength
10MG;EQ 5MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 211533
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
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.
