Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087770
Company: IVAX PHARMS
Company: IVAX PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SULFINPYRAZONE | SULFINPYRAZONE | 200MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 11/19/1982 | 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 |
|---|---|---|---|---|---|
| 01/28/2000 | SUPPL-15 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/23/1999 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/20/1999 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/06/1995 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 04/12/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1993 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/16/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 01/25/1991 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/25/1991 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |