Drugs@FDA: FDA-Approved Drugs
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| K-TAB | POTASSIUM CHLORIDE | 10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| K-TAB | POTASSIUM CHLORIDE | 8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| K-TAB | POTASSIUM CHLORIDE | 20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 06/09/1980 | 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-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018279Orig1s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018279Orig1s037ltr.pdf | |
| 06/26/2014 | SUPPL-34 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018279s034lbl.pdf | |
| 11/25/2013 | SUPPL-33 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018279s033lbl.pdf | |
| 06/03/2014 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/01/2013 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/2014 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/15/2012 | SUPPL-29 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018279s029ltr.pdf |
| 12/14/2004 | SUPPL-27 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18279s027ltr.pdf |
| 12/24/2002 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/02/2002 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/16/1998 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/29/1997 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/21/1996 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/27/1993 | SUPPL-20 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/26/1990 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/02/1989 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/01/1988 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 08/01/1988 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/12/1987 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/17/1986 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/07/1986 | SUPPL-11 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/14/1986 | SUPPL-10 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/25/1985 | SUPPL-9 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 08/13/1984 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 08/01/1984 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/02/1982 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 11/10/1982 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 04/29/1981 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/16/1981 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/1981 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/04/1981 | SUPPL-1 | Manufacturing (CMC)-Packaging |
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-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018279Orig1s037lbl.pdf | |
| 06/26/2014 | SUPPL-34 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018279s034lbl.pdf |
| 11/25/2013 | SUPPL-33 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018279s033lbl.pdf |