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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214912
Company: LYNE

Products on ANDA 214912

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM POLYSTYRENE SULFONATE	SODIUM POLYSTYRENE SULFONATE	15GM/60ML	SUSPENSION;ORAL, RECTAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214912

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/10/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 214912

SODIUM POLYSTYRENE SULFONATE

SUSPENSION;ORAL, RECTAL; 15GM/60ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KIONEX	SODIUM POLYSTYRENE SULFONATE	15GM/60ML	SUSPENSION;ORAL, RECTAL	Prescription	No	AA	040028	ANI PHARMS
SODIUM POLYSTYRENE SULFONATE	SODIUM POLYSTYRENE SULFONATE	15GM/60ML	SUSPENSION;ORAL, RECTAL	Prescription	No	AA	214912	LYNE
SPS	SODIUM POLYSTYRENE SULFONATE	15GM/60ML	SUSPENSION;ORAL, RECTAL	Prescription	Yes	AA	087859	CMP PHARMA INC

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