Drugs@FDA: FDA-Approved Drugs
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SLOW-K | POTASSIUM CHLORIDE | 8MEQ | TABLET, 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 |
|---|---|---|---|---|---|---|---|
| 04/25/1975 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 11/24/2004 | SUPPL-45 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17476s044,045ltr.pdf |
| 11/24/2004 | SUPPL-44 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17476s044,045ltr.pdf |
| 04/28/1999 | SUPPL-43 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/22/1996 | SUPPL-41 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/30/1992 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/20/1991 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/08/1989 | SUPPL-38 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/23/1988 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 10/31/1986 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/21/1985 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/19/1985 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/14/1984 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/22/1984 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/06/1983 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/22/1982 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/14/1981 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/14/1981 | SUPPL-27 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/21/1981 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/13/1980 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/21/1980 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/02/1982 | SUPPL-23 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/04/1979 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/03/1979 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/03/1979 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/03/1979 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/03/1980 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 07/08/1982 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/09/1978 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/27/1977 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 04/07/1981 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1979 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/08/1977 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/08/1977 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/1977 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/07/1976 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1976 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1976 | SUPPL-7 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/01/1976 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/18/1975 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/09/1976 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/20/1975 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |