Orange Book product · Generic (ANDA)
LINAGLIPTIN
LINAGLIPTIN
At a glance
Sep 03, 2024
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 03, 2024
1 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
LINAGLIPTIN
Strength
5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 208423
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of LINAGLIPTIN
- 2011TRADJENTABrand (NDA)
NDA 201280 · BOEHRINGER INGELHEIM
- 2026LINAGLIPTINGeneric (ANDA)
ANDA 208433 · TEVA PHARMS USA
- 2025LINAGLIPTINGeneric (ANDA)
ANDA 208415 · AUROBINDO PHARMA LTD
- 2025LINAGLIPTINGeneric (ANDA)
ANDA 208428 · DR REDDYS
- 2025LINAGLIPTINGeneric (ANDA)
ANDA 208457 · MSN
- 2025LINAGLIPTINGeneric (ANDA)
ANDA 208431 · MYLAN
- 2023LINAGLIPTINGeneric (ANDA)
ANDA 208448 · ZYDUS PHARMS
- 2021LINAGLIPTINGeneric (ANDA)
ANDA 208335 · 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.
