Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
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 |
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-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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08/03/2005 | SUPPL-34 | Labeling |
Label is not available on this site. |
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05/03/2001 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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03/18/2002 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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05/31/2000 | SUPPL-28 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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03/07/2002 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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03/31/1998 | SUPPL-26 | Labeling |
Label is not available on this site. |
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03/31/1998 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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03/31/1998 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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03/31/1998 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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03/31/1998 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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03/31/1998 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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08/28/1996 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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11/14/1995 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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08/15/1994 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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08/27/1993 | SUPPL-17 | Labeling |
Label is not available on this site. |
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12/16/1993 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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08/11/1992 | SUPPL-15 | Labeling |
Label is not available on this site. |
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03/16/1992 | SUPPL-14 | Labeling |
Label is not available on this site. |
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05/02/1991 | SUPPL-12 | Labeling |
Label is not available on this site. |
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05/02/1991 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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05/02/1991 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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05/02/1991 | SUPPL-9 | Labeling |
Label is not available on this site. |
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09/02/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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09/02/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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05/03/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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05/03/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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05/03/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |