Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040905
Company: KVK TECH

Products on ANDA 040905

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KALEXATE	SODIUM POLYSTYRENE SULFONATE	454GM/BOT	POWDER;ORAL, RECTAL	Prescription	AA	No	Yes
KALEXATE	SODIUM POLYSTYRENE SULFONATE	15GM/BOT	POWDER;ORAL, RECTAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040905

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/30/2009	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/21/2020	SUPPL-6	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
11/08/2011	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 040905

KALEXATE

POWDER;ORAL, RECTAL; 454GM/BOT
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KALEXATE	SODIUM POLYSTYRENE SULFONATE	454GM/BOT	POWDER;ORAL, RECTAL	Prescription	No	AA	040905	KVK TECH
KIONEX	SODIUM POLYSTYRENE SULFONATE	454GM/BOT	POWDER;ORAL, RECTAL	Prescription	No	AA	040029	ANI PHARMS
SODIUM POLYSTYRENE SULFONATE	SODIUM POLYSTYRENE SULFONATE	454GM/BOT	POWDER;ORAL, RECTAL	Prescription	No	AA	205727	BELCHER
SODIUM POLYSTYRENE SULFONATE	SODIUM POLYSTYRENE SULFONATE	454GM/BOT	POWDER;ORAL, RECTAL	Prescription	No	AA	206815	CHARTWELL RX
SODIUM POLYSTYRENE SULFONATE	SODIUM POLYSTYRENE SULFONATE	454GM/BOT	POWDER;ORAL, RECTAL	Prescription	No	AA	089910	CMP PHARMA INC
SODIUM POLYSTYRENE SULFONATE	SODIUM POLYSTYRENE SULFONATE	454GM/BOT	POWDER;ORAL, RECTAL	Prescription	No	AA	204071	NUVO PHARMS INC