Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 010909
Company: SCHERING
Company: SCHERING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MIRADON | ANISINDIONE | 50MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 04/05/1957 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 02/06/2002 | SUPPL-13 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10909s13ltr.pdf |
| 01/12/1995 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/30/1994 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 04/05/1989 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 08/08/1986 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 11/18/1981 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/18/1981 | SUPPL-5 | Labeling |
Label is not available on this site. |