Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214489
Company: LUPIN

Products on ANDA 214489

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AZILSARTAN MEDOXOMIL	AZILSARTAN KAMEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET;ORAL	Prescription	AB	No	No
AZILSARTAN MEDOXOMIL	AZILSARTAN KAMEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214489

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/20/2022	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214489Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/18/2024	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 214489

AZILSARTAN MEDOXOMIL

TABLET;ORAL; EQ 40MG MEDOXOMIL
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AZILSARTAN MEDOXOMIL	AZILSARTAN KAMEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET;ORAL	Prescription	No	AB	214489	LUPIN
EDARBI	AZILSARTAN KAMEDOXOMIL	EQ 40MG MEDOXOMIL	TABLET;ORAL	Prescription	Yes	AB	200796	AZURITY

TABLET;ORAL; EQ 80MG MEDOXOMIL
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AZILSARTAN MEDOXOMIL	AZILSARTAN KAMEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET;ORAL	Prescription	No	AB	214489	LUPIN
EDARBI	AZILSARTAN KAMEDOXOMIL	EQ 80MG MEDOXOMIL	TABLET;ORAL	Prescription	Yes	AB	200796	AZURITY