Drugs@FDA: FDA-Approved Drugs
Company: SCHERING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
06/13/1986 | 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 |
---|---|---|---|---|---|
06/13/2008 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019439s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019439s022ltr.pdf | |
02/21/2001 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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09/01/2000 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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03/21/1997 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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11/15/1996 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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11/08/1993 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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12/20/1990 | SUPPL-15 | Labeling |
Label is not available on this site. |
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08/08/1989 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
03/15/1989 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/03/1990 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/04/1989 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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03/15/1989 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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10/26/1988 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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10/04/1988 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/02/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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05/05/1988 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/23/1988 | SUPPL-3 | Labeling |
Label is not available on this site. |
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08/12/1987 | SUPPL-2 | Labeling |
Label is not available on this site. |
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08/23/1988 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/13/2008 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019439s022lbl.pdf |