Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080197
Company: CHARTWELL
Company: CHARTWELL
| 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 |
|---|---|---|---|---|---|---|---|
| 11/12/1973 | 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 |
|---|---|---|---|---|---|
| 08/24/2023 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/24/2023 | SUPPL-31 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/24/2023 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/21/1997 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/1994 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/1994 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 05/28/1993 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/28/1993 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 04/26/1991 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 02/08/1991 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 08/01/1989 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 06/29/1988 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1988 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/13/1983 | SUPPL-11 | 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 |