Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206665
Company: ENDO OPERATIONS

Products on ANDA 206665

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALISKIREN HEMIFUMARATE	ALISKIREN HEMIFUMARATE	EQ 150MG BASE	TABLET;ORAL	Prescription	AB	No	No
ALISKIREN HEMIFUMARATE	ALISKIREN HEMIFUMARATE	EQ 300MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206665

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/22/2019	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206665Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/19/2023	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 206665

ALISKIREN HEMIFUMARATE

TABLET;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALISKIREN HEMIFUMARATE	ALISKIREN HEMIFUMARATE	EQ 150MG BASE	TABLET;ORAL	Prescription	No	AB	206665	ENDO OPERATIONS
TEKTURNA	ALISKIREN HEMIFUMARATE	EQ 150MG BASE	TABLET;ORAL	Prescription	Yes	AB	021985	NODEN PHARMA

TABLET;ORAL; EQ 300MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALISKIREN HEMIFUMARATE	ALISKIREN HEMIFUMARATE	EQ 300MG BASE	TABLET;ORAL	Prescription	No	AB	206665	ENDO OPERATIONS
TEKTURNA	ALISKIREN HEMIFUMARATE	EQ 300MG BASE	TABLET;ORAL	Prescription	Yes	AB	021985	NODEN PHARMA