Drugs@FDA: FDA-Approved Drugs
Company: APOTHECON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KLOTRIX | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 05/22/1980 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 10/03/1995 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/03/1990 | SUPPL-27 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 09/19/1989 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 06/15/1988 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/07/1988 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 08/26/1988 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 10/01/1987 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/15/1987 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 02/13/1987 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/11/1987 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/24/1985 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/24/1985 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/24/1985 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/30/1985 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/15/1985 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/14/1985 | SUPPL-13 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 06/09/1983 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/09/1983 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/04/1983 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/04/1983 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/04/1983 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/04/1983 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/04/1982 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/01/1981 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 08/13/1984 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 03/17/1981 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/14/1980 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/14/1980 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |