Orange Book product · Generic (ANDA)
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Generic (ANDA)ANDA 207678TE ABRX DR REDDYS LABS SA
At a glance
Aug 09, 2023
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 09, 2023
2 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Strength
500MG;EQ 5MG BASE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
ANDA 207678
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of METFORMIN HYDROCHLORIDE; 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.
