Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089049
Company: WEST-WARD PHARMS INT
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
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.

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 PADDOCK LLC
SODIUM POLYSTYRENE SULFONATE SODIUM POLYSTYRENE SULFONATE 15GM/60ML SUSPENSION;ORAL, RECTAL Prescription No AA 090590 PADDOCK LLC
SODIUM POLYSTYRENE SULFONATE SODIUM POLYSTYRENE SULFONATE 15GM/60ML SUSPENSION;ORAL, RECTAL Prescription No AA 089049 WEST-WARD PHARMS INT
SPS SODIUM POLYSTYRENE SULFONATE 15GM/60ML SUSPENSION;ORAL, RECTAL Prescription No AA 087859 CMP PHARMA INC

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