Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018689
Company: SEBELA IRELAND LTD
Company: SEBELA IRELAND LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RIDAURA | AURANOFIN | 3MG | CAPSULE;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/24/1985 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018689Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/14/2013 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/23/2002 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/1999 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 12/22/1999 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/02/1996 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/1998 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 04/23/1998 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 04/13/1989 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 11/02/1987 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 11/02/1987 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 04/27/1987 | SUPPL-6 | Labeling |
Label is not available on this site. |