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; CHLORTHALIDONE	AZILSARTAN MEDOXOMIL;CHLORTHALIDONE	40MG;12.5MG	TABLET;ORAL	None (Tentative Approval)	None	No	No
AZILSARTAN MEDOXOMIL; CHLORTHALIDONE	AZILSARTAN MEDOXOMIL;CHLORTHALIDONE	40MG;25MG	TABLET;ORAL	None (Tentative Approval)	None	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
11/28/2023	ORIG-1	Tentative Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217490Orig1s000TA_ltr.pdf