Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 060575
Company: DELCOR ASSET CORP
Company: DELCOR ASSET CORP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MYCOSTATIN | NYSTATIN | 100,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM;TOPICAL | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 02/09/1965 | 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 |
|---|---|---|---|---|---|
| 03/16/1993 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 09/11/1991 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/23/1992 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/28/1990 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/17/1998 | SUPPL-8 | Labeling |
Label is not available on this site. |