Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 220421
Company: HETERO LABS LIMITED, VEMAGAL

Products on ANDA 220421

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM SULFATE, MAGNESIUM SULFATE AND POTASSIUM CHLORIDE	SODIUM SULFATE, MAGNESIUM SULFATE, UNSPECIFIED FORM, POTASSIUM CHLORIDE	1.479G, 0.225G, 0.188G	TABLET	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 220421

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/01/2026	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.