Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087585
Company: LUITPOLD
Company: LUITPOLD
| 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 |
|---|---|---|---|---|---|---|---|
| 06/30/1981 | 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 |
|---|---|---|---|---|---|
| 11/07/1997 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/06/1996 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/28/1996 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/11/1993 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/11/1993 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 11/22/1991 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 02/04/1991 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 07/29/1991 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/18/1989 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/27/1991 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/03/1988 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 01/13/1986 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/13/1986 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/19/1984 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/19/1984 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/13/1983 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/16/1982 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/22/1982 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |