Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089910
Company: CMP PHARMA INC
Company: CMP PHARMA INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SODIUM POLYSTYRENE SULFONATE | SODIUM POLYSTYRENE SULFONATE | 454GM/BOT | POWDER;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 |
---|---|---|---|---|---|---|---|
01/19/1989 | 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 |
---|---|---|---|---|---|
01/29/2018 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
09/25/2012 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
10/31/2000 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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11/04/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
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12/04/1991 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
SODIUM POLYSTYRENE SULFONATE
POWDER;ORAL, RECTAL; 454GM/BOT
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
KALEXATE | SODIUM POLYSTYRENE SULFONATE | 454GM/BOT | POWDER;ORAL, RECTAL | Prescription | No | AA | 040905 | KVK TECH |
KIONEX | SODIUM POLYSTYRENE SULFONATE | 454GM/BOT | POWDER;ORAL, RECTAL | Prescription | No | AA | 040029 | ANI PHARMS |
SODIUM POLYSTYRENE SULFONATE | SODIUM POLYSTYRENE SULFONATE | 454GM/BOT | POWDER;ORAL, RECTAL | Prescription | No | AA | 205727 | BELCHER |
SODIUM POLYSTYRENE SULFONATE | SODIUM POLYSTYRENE SULFONATE | 454GM/BOT | POWDER;ORAL, RECTAL | Prescription | No | AA | 206815 | CHARTWELL RX |
SODIUM POLYSTYRENE SULFONATE | SODIUM POLYSTYRENE SULFONATE | 454GM/BOT | POWDER;ORAL, RECTAL | Prescription | No | AA | 089910 | CMP PHARMA INC |
SODIUM POLYSTYRENE SULFONATE | SODIUM POLYSTYRENE SULFONATE | 454GM/BOT | POWDER;ORAL, RECTAL | Prescription | No | AA | 204071 | NUVO PHARMS INC |