Drugs@FDA: FDA-Approved Drugs
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OCL | POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE | 6GM/100ML;75MG/100ML;168MG/100ML;146MG/100ML;1.29GM/100ML | SOLUTION;ORAL | 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 |
---|---|---|---|---|---|---|---|
04/30/1986 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/17/2000 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/07/2007 | SUPPL-13 | Labeling |
Label is not available on this site. |
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11/04/1999 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/07/2007 | SUPPL-11 | Labeling |
Label is not available on this site. |
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02/03/1998 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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12/07/2007 | SUPPL-9 | Labeling |
Label is not available on this site. |
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07/30/1996 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/13/1992 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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11/22/1988 | SUPPL-5 | Labeling |
Label is not available on this site. |
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09/30/1988 | SUPPL-4 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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11/25/1987 | SUPPL-3 | Labeling |
Label is not available on this site. |
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09/30/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |