Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 083163
Company: INTL MEDICATION
Company: INTL MEDICATION
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 2MEQ/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 08/29/1975 | 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 |
|---|---|---|---|---|---|
| 03/21/2023 | SUPPL-27 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 12/02/2022 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/18/1996 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/19/1995 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/18/1996 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 06/18/1996 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/17/1994 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/14/1998 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/29/1993 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/27/1993 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/03/1993 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/26/1992 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 06/15/1992 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 04/04/1991 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 02/07/1991 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/07/1991 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/05/1987 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/05/1987 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/12/1987 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |