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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213676
Company: LAURUS

Products on ANDA 213676

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 213676

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/2024/213676Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 213676

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

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