Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 061533
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/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 |
|---|---|---|---|---|---|---|---|
| 02/25/1972 | 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 |
|---|---|---|---|---|---|
| 10/16/1995 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/16/1996 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 01/11/1994 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/07/1992 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 11/02/1992 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 06/19/1992 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/25/1992 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 08/21/1990 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 03/29/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |