Drugs@FDA: FDA-Approved Drugs
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SULFASALAZINE | SULFASALAZINE | 500MG | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 10/21/1977 | 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 |
|---|---|---|---|---|---|
| 07/26/2022 | SUPPL-42 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/26/2022 | SUPPL-40 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/25/2015 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/25/2015 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/21/2013 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/31/2010 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/05/2003 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 10/27/1998 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 04/23/1998 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 10/08/1997 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/08/1997 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/27/1997 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1993 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 07/22/1991 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 05/21/1991 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 08/15/1988 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/15/1988 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/15/1988 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/15/1988 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/1988 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/20/1987 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/20/1987 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/20/1987 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/15/1986 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/22/1983 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/13/1983 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/13/1983 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
SULFASALAZINE
TABLET;ORAL; 500MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AZULFIDINE | SULFASALAZINE | 500MG | TABLET;ORAL | Prescription | Yes | AB | 007073 | PFIZER |
| SULFASALAZINE | SULFASALAZINE | 500MG | TABLET;ORAL | Prescription | No | AB | 080197 | CHARTWELL |
| SULFASALAZINE | SULFASALAZINE | 500MG | TABLET;ORAL | Prescription | No | AB | 040349 | NUVO PHARMS INC |
| SULFASALAZINE | SULFASALAZINE | 500MG | TABLET;ORAL | Prescription | No | AB | 085828 | WATSON LABS |