Orange Book product · Generic (ANDA)
SACUBITRIL AND VALSARTAN
SACUBITRIL; VALSARTAN
At a glance
Sep 16, 2024
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 16, 2024
1 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
SACUBITRIL; VALSARTAN
Strength
24MG;26MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 213764
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 213680 · BIOCON PHARMA
- 2024SACUBITRIL AND VALSARTANGeneric (ANDA)
ANDA 213604 · TORRENT
- 2024SACUBITRIL AND VALSARTANGeneric (ANDA)
ANDA 213719 · ZYDUS PHARMS
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.
