An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 213682
Company: ALEMBIC

Products on ANDA 213682

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	24MG;26MG	TABLET;ORAL	Prescription	AB	No	No
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	49MG;51MG	TABLET;ORAL	Prescription	AB	No	No
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	97MG;103MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213682

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/28/2024	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213682Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 213682

SACUBITRIL AND VALSARTAN

TABLET;ORAL; 24MG;26MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ENTRESTO	SACUBITRIL; VALSARTAN	24MG;26MG	TABLET;ORAL	Prescription	Yes	AB	207620	NOVARTIS PHARMS CORP
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	24MG;26MG	TABLET;ORAL	Prescription	No	AB	213682	ALEMBIC
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	24MG;26MG	TABLET;ORAL	Prescription	No	AB	213764	ALKEM LABS LTD
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	24MG;26MG	TABLET;ORAL	Prescription	No	AB	213680	BIOCON PHARMA
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	24MG;26MG	TABLET;ORAL	Prescription	No	AB	213605	CRYSTAL
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	24MG;26MG	TABLET;ORAL	Prescription	No	AB	213627	DR REDDYS
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	24MG;26MG	TABLET;ORAL	Prescription	No	AB	213676	LAURUS
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	24MG;26MG	TABLET;ORAL	Prescription	No	AB	213808	LUPIN
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	24MG;26MG	TABLET;ORAL	Prescription	No	AB	213728	MACLEODS PHARMS LTD
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	24MG;26MG	TABLET;ORAL	Prescription	No	AB	213748	MSN
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	24MG;26MG	TABLET;ORAL	Prescription	No	AB	213604	TORRENT
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	24MG;26MG	TABLET;ORAL	Prescription	No	AB	213719	ZYDUS PHARMS

TABLET;ORAL; 49MG;51MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ENTRESTO	SACUBITRIL; VALSARTAN	49MG;51MG	TABLET;ORAL	Prescription	Yes	AB	207620	NOVARTIS PHARMS CORP
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	49MG;51MG	TABLET;ORAL	Prescription	No	AB	213682	ALEMBIC
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	49MG;51MG	TABLET;ORAL	Prescription	No	AB	213764	ALKEM LABS LTD
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	49MG;51MG	TABLET;ORAL	Prescription	No	AB	213680	BIOCON PHARMA
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	49MG;51MG	TABLET;ORAL	Prescription	No	AB	213605	CRYSTAL
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	49MG;51MG	TABLET;ORAL	Prescription	No	AB	213627	DR REDDYS
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	49MG;51MG	TABLET;ORAL	Prescription	No	AB	213676	LAURUS
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	49MG;51MG	TABLET;ORAL	Prescription	No	AB	213808	LUPIN
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	49MG;51MG	TABLET;ORAL	Prescription	No	AB	213728	MACLEODS PHARMS LTD
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	49MG;51MG	TABLET;ORAL	Prescription	No	AB	213748	MSN
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	49MG;51MG	TABLET;ORAL	Prescription	No	AB	213604	TORRENT
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	49MG;51MG	TABLET;ORAL	Prescription	No	AB	213719	ZYDUS PHARMS

TABLET;ORAL; 97MG;103MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ENTRESTO	SACUBITRIL; VALSARTAN	97MG;103MG	TABLET;ORAL	Prescription	Yes	AB	207620	NOVARTIS PHARMS CORP
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	97MG;103MG	TABLET;ORAL	Prescription	No	AB	213682	ALEMBIC
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	97MG;103MG	TABLET;ORAL	Prescription	No	AB	213764	ALKEM LABS LTD
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	97MG;103MG	TABLET;ORAL	Prescription	No	AB	213680	BIOCON PHARMA
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	97MG;103MG	TABLET;ORAL	Prescription	No	AB	213605	CRYSTAL
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	97MG;103MG	TABLET;ORAL	Prescription	No	AB	213627	DR REDDYS
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	97MG;103MG	TABLET;ORAL	Prescription	No	AB	213676	LAURUS
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	97MG;103MG	TABLET;ORAL	Prescription	No	AB	213808	LUPIN
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	97MG;103MG	TABLET;ORAL	Prescription	No	AB	213728	MACLEODS PHARMS LTD
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	97MG;103MG	TABLET;ORAL	Prescription	No	AB	213748	MSN
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	97MG;103MG	TABLET;ORAL	Prescription	No	AB	213604	TORRENT
SACUBITRIL AND VALSARTAN	SACUBITRIL; VALSARTAN	97MG;103MG	TABLET;ORAL	Prescription	No	AB	213719	ZYDUS PHARMS

Top