Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088483
Company: ODYSSEY PHARMS
Company: ODYSSEY PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ANTABUSE | DISULFIRAM | 500MG | TABLET;ORAL | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 12/08/1983 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/88483ap.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/13/2014 | SUPPL-27 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 11/18/2003 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 06/14/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 04/07/1997 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 12/20/1994 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/1994 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1993 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 07/14/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/1985 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |