Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088786
Company: WOCKHARDT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM POLYSTYRENE SULFONATE SODIUM POLYSTYRENE SULFONATE 453.6GM/BOT POWDER;ORAL, RECTAL Discontinued None 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
09/11/1984 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
11/08/1991 SUPPL-6 Labeling

Label is not available on this site.

01/30/1990 SUPPL-5 Labeling

Label is not available on this site.

08/29/1989 SUPPL-4 Labeling

Label is not available on this site.

03/06/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/06/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/23/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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