Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217558
Company: ALKEM LABS LTD

Products on ANDA 217558

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM ZIRCONIUM CYCLOSILICATE	SODIUM ZIRCONIUM CYCLOSILICATE	5G	POWDER, FOR SUSPENSION	None (Tentative Approval)	None	No	No
SODIUM ZIRCONIUM CYCLOSILICATE	SODIUM ZIRCONIUM CYCLOSILICATE	10G	POWDER, FOR SUSPENSION	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217558

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/08/2025	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.