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. |
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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. |
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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. |
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10/27/1998 | SUPPL-33 | Labeling |
Label is not available on this site. |
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04/23/1998 | SUPPL-32 | Labeling |
Label is not available on this site. |
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10/08/1997 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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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. |
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07/22/1991 | SUPPL-27 | Labeling |
Label is not available on this site. |
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05/21/1991 | SUPPL-26 | Labeling |
Label is not available on this site. |
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08/15/1988 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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08/15/1988 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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08/15/1988 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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08/15/1988 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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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. |
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05/13/1983 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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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 |