Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217490
Company: ALKEM LABS LTD

Products on ANDA 217490

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE	AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE	EQ 40MG MEDOXOMIL;12.5MG	TABLET;ORAL	Prescription	AB	No	No
AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE	AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE	EQ 40MG MEDOXOMIL;25MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217490

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/21/2025	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/217490Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 217490

AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE

TABLET;ORAL; EQ 40MG MEDOXOMIL;12.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE	AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE	EQ 40MG MEDOXOMIL;12.5MG	TABLET;ORAL	Prescription	No	AB	217490	ALKEM LABS LTD
EDARBYCLOR	AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE	EQ 40MG MEDOXOMIL;12.5MG	TABLET;ORAL	Prescription	Yes	AB	202331	AZURITY

TABLET;ORAL; EQ 40MG MEDOXOMIL;25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE	AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE	EQ 40MG MEDOXOMIL;25MG	TABLET;ORAL	Prescription	No	AB	217490	ALKEM LABS LTD
EDARBYCLOR	AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE	EQ 40MG MEDOXOMIL;25MG	TABLET;ORAL	Prescription	Yes	AB	202331	AZURITY