Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087197
Company: WATSON LABS
Company: WATSON LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SULFASALAZINE | SULFASALAZINE | 500MG | TABLET;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 |
---|---|---|---|---|---|---|---|
04/02/1981 | 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 |
---|---|---|---|---|---|
10/06/1992 | SUPPL-13 | Labeling |
Label is not available on this site. |
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08/12/1991 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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01/28/1991 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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08/07/1991 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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05/03/1984 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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04/27/1983 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |