Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 060578
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MYCOSTATIN | NYSTATIN | 100,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER;TOPICAL | Discontinued | None | No | No |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 |
---|---|---|---|---|---|---|---|
09/08/1964 | 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 |
---|---|---|---|---|---|
11/30/1992 | SUPPL-6 | Labeling |
Label is not available on this site. |
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06/19/1992 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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09/17/1998 | SUPPL-3 | Labeling |
Label is not available on this site. |