Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062065
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NYSTATIN | NYSTATIN | 500,000 UNITS | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 09/16/1994 | 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 |
|---|---|---|---|---|---|
| 08/29/1995 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/1996 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 10/27/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/13/1995 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/27/1995 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/12/1996 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 09/11/1992 | SUPPL-9 | Labeling |
Label is not available on this site. |