Drugs@FDA: FDA-Approved Drugs
Company: NESHER PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MICRO-K | POTASSIUM CHLORIDE | 8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| MICRO-K 10 | POTASSIUM CHLORIDE | 10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 10/17/1980 | 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 |
|---|---|---|---|---|---|
| 04/30/2018 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018238s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018238Orig1s046ltr.pdf | |
| 03/09/2016 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/2015 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/26/2014 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/2014 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/18/2013 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/2013 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/14/2013 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/20/2003 | SUPPL-31 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18238slr031ltr.pdf |
| 05/08/2000 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/10/2000 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/09/2000 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/13/1998 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/19/1993 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/12/1990 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/30/1998 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 01/30/1998 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 06/30/1988 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/10/1987 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/26/1987 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/23/1986 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/14/1986 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/25/1985 | SUPPL-16 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/08/1985 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/25/1985 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018238_s013_MICROK.pdf |
| 03/16/1984 | SUPPL-12 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/14/1984 | SUPPL-11 | Efficacy |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018238_s011_MICRO-K.pdf |
| 05/04/1983 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/03/1983 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/23/1982 | SUPPL-7 | Unspecified |
Label is not available on this site. |
||
| 03/03/1982 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/03/1982 | SUPPL-5 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/08/1982 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/17/1982 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/02/1981 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/13/1981 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/30/2018 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018238s046lbl.pdf |