Orange Book product · Generic (ANDA)
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE
LINAGLIPTIN; METFORMIN HYDROCHLORIDE
At a glance
Nov 03, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 03, 2025
8 mo ago
Today
Pharmaceutical detail
Active ingredient
LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Strength
2.5MG;1GM
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 208459
Product number
003
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of LINAGLIPTIN; METFORMIN HYDROCHLORIDE
- 2016JENTADUETO XRBrand (NDA)
NDA 208026 · BOEHRINGER INGELHEIM
- 2012JENTADUETOBrand (NDA)
NDA 201281 · BOEHRINGER INGELHEIM
- 2025LINAGLIPTIN AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 208427 · DR REDDYS
- 2023LINAGLIPTIN AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 208449 · ZYDUS PHARMS
- 2021LINAGLIPTIN AND METFORMIN HYDROCHLORIDEGeneric (ANDA)
ANDA 208336 · SUNSHINE
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.
