Drugs@FDA: FDA-Approved Drugs
Company: COSETTE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NYSTATIN | NYSTATIN | 100,000 UNITS/ML | SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 12/17/1987 | 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 |
|---|---|---|---|---|---|
| 08/30/2001 | SUPPL-27 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/19/1997 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/19/1997 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/1996 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/26/1995 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/26/1995 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/26/1995 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/04/1995 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/04/1995 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/03/1993 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/03/1993 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/21/1993 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/21/1993 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/21/1993 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/21/1993 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/21/1993 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/21/1993 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1993 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1993 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1993 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/09/1994 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 05/21/1992 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 06/01/1992 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/24/1989 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |