Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070980
Company: NESHER PHARMS
Company: NESHER PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | CAPSULE, 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 |
|---|---|---|---|---|---|---|---|
| 02/17/1987 | 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 |
|---|---|---|---|---|---|
| 03/13/2002 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/25/2000 | SUPPL-22 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 11/30/2000 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 11/30/2000 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/30/2000 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/04/1999 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/30/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/16/1993 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/19/1992 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/22/1992 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/28/1992 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 02/28/1992 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 02/15/1991 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/06/1991 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/25/1990 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/22/1989 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 12/22/1989 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |