Orange Book product · Generic (ANDA)
SACUBITRIL AND VALSARTAN
SACUBITRIL; VALSARTAN
At a glance
May 28, 2024
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 28, 2024
2 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
SACUBITRIL; VALSARTAN
Strength
24MG;26MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 213605
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of SACUBITRIL; VALSARTAN
- 2024ENTRESTO SPRINKLEBrand (NDA)
NDA 218591 · NOVARTIS
- 2015ENTRESTOBrand (NDA)
NDA 207620 · NOVARTIS PHARMS CORP
- 2026SACUBITRIL AND VALSARTANGeneric (ANDA)
ANDA 219983 · SOMERSET THERAPS LLC
- 2025SACUBITRIL AND VALSARTANGeneric (ANDA)
ANDA 213668 · HETERO LABS LTD III
- 2025SACUBITRIL AND VALSARTANGeneric (ANDA)
ANDA 213748 · MSN
- 2025SACUBITRIL AND VALSARTANGeneric (ANDA)
ANDA 213611 · NOVUGEN PHARMA SDN
- 2025SACUBITRIL AND VALSARTANGeneric (ANDA)
ANDA 213627 · DR REDDYS
- 2025SACUBITRIL AND VALSARTANGeneric (ANDA)
ANDA 213808 · LUPIN
- 2024SACUBITRIL AND VALSARTANGeneric (ANDA)
ANDA 213728 · MACLEODS PHARMS LTD
- 2024SACUBITRIL AND VALSARTANGeneric (ANDA)
ANDA 213764 · ALKEM LABS LTD
- 2024SACUBITRIL AND VALSARTANGeneric (ANDA)
ANDA 213680 · BIOCON PHARMA
- 2024SACUBITRIL AND VALSARTANGeneric (ANDA)
ANDA 213604 · TORRENT
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.
