Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089049
Company: HIKMA

Products on ANDA 089049

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	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 089049

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/17/1986	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
10/19/2012	SUPPL-39	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
08/03/2005	SUPPL-34	Labeling		Label is not available on this site.
05/03/2001	SUPPL-30	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/18/2002	SUPPL-29	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/31/2000	SUPPL-28	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
03/07/2002	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
03/31/1998	SUPPL-26	Labeling		Label is not available on this site.
03/31/1998	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
03/31/1998	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
03/31/1998	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
03/31/1998	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
03/31/1998	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
08/28/1996	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
11/14/1995	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
08/15/1994	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
08/27/1993	SUPPL-17	Labeling		Label is not available on this site.
12/16/1993	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
08/11/1992	SUPPL-15	Labeling		Label is not available on this site.
03/16/1992	SUPPL-14	Labeling		Label is not available on this site.
05/02/1991	SUPPL-12	Labeling		Label is not available on this site.
05/02/1991	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
05/02/1991	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
05/02/1991	SUPPL-9	Labeling		Label is not available on this site.
09/02/1988	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
09/02/1988	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
05/03/1988	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
05/03/1988	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
05/03/1988	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.