Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217549
Company: LUPIN

Products on ANDA 217549

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM ZIRCONIUM CYCLOSILICATE	SODIUM ZIRCONIUM CYCLOSILICATE	5GM/PACKET	FOR SUSPENSION;ORAL	Prescription	AB	No	No
SODIUM ZIRCONIUM CYCLOSILICATE	SODIUM ZIRCONIUM CYCLOSILICATE	10GM/PACKET	FOR SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217549

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/07/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217549

SODIUM ZIRCONIUM CYCLOSILICATE

FOR SUSPENSION;ORAL; 5GM/PACKET
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LOKELMA	SODIUM ZIRCONIUM CYCLOSILICATE	5GM/PACKET	FOR SUSPENSION;ORAL	Prescription	Yes	AB	207078	ASTRAZENECA
SODIUM ZIRCONIUM CYCLOSILICATE	SODIUM ZIRCONIUM CYCLOSILICATE	5GM/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	217549	LUPIN

FOR SUSPENSION;ORAL; 10GM/PACKET
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LOKELMA	SODIUM ZIRCONIUM CYCLOSILICATE	10GM/PACKET	FOR SUSPENSION;ORAL	Prescription	Yes	AB	207078	ASTRAZENECA
SODIUM ZIRCONIUM CYCLOSILICATE	SODIUM ZIRCONIUM CYCLOSILICATE	10GM/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	217549	LUPIN