Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050619
Company: DELCOR ASSET CORP
Company: DELCOR ASSET CORP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MYCOSTATIN | NYSTATIN | 200,000 UNITS | PASTILLE;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 |
|---|---|---|---|---|---|---|---|
| 04/09/1987 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/30/2003 | SUPPL-4 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/r_50619slr004ltr.pdf |
| 02/11/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/13/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 04/26/1994 | SUPPL-1 | Labeling |
Label is not available on this site. |