Drugs@FDA: FDA-Approved Drugs
Company: CMP PHARMA INC
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 |
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. |
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03/03/2011 | SUPPL-24 | Labeling |
Label is not available on this site. |
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03/03/2011 | SUPPL-23 | Labeling |
Label is not available on this site. |
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03/18/2004 | SUPPL-20 | Labeling |
Label is not available on this site. |
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11/30/2000 | SUPPL-18 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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05/31/1991 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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12/12/1991 | SUPPL-13 | Labeling |
Label is not available on this site. |
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07/18/1989 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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07/16/1987 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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12/12/1985 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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04/27/1983 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
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 |