Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040028
Company: ANI PHARMS

Products on ANDA 040028

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040028

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/17/2007	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2007/040028Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/03/2024	SUPPL-19	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
10/18/2022	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
04/26/2015	SUPPL-12	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 040028

KIONEX

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
SPS	SODIUM POLYSTYRENE SULFONATE	15GM/60ML	SUSPENSION;ORAL, RECTAL	Prescription	Yes	AA	087859	CMP PHARMA INC