Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087859
Company: CMP PHARMA INC

Products on ANDA 087859

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SPS	SODIUM POLYSTYRENE SULFONATE	15GM/60ML	SUSPENSION;ORAL, RECTAL	Prescription	AA	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087859

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/08/1982	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
06/24/2011	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
03/03/2011	SUPPL-24	Labeling		Label is not available on this site.
03/03/2011	SUPPL-23	Labeling		Label is not available on this site.
03/18/2004	SUPPL-20	Labeling		Label is not available on this site.
11/30/2000	SUPPL-18	Manufacturing (CMC)-Facility		Label is not available on this site.
05/31/1991	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
12/12/1991	SUPPL-13	Labeling		Label is not available on this site.
07/18/1989	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
07/16/1987	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
12/12/1985	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
04/27/1983	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 087859

SPS

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