Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062615
Company: ODYSSEY PHARMS
Company: ODYSSEY PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NYSTATIN | NYSTATIN | 100,000 UNITS | TABLET;VAGINAL | 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 |
|---|---|---|---|---|---|---|---|
| 10/17/1985 | 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 |
|---|---|---|---|---|---|
| 05/24/2001 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/05/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/1994 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1991 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/13/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |