Drugs@FDA: FDA-Approved Drugs
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SULINDAC | SULINDAC | 200MG | TABLET;ORAL | Discontinued | None | No | No |
SULINDAC | SULINDAC | 150MG | 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 |
---|---|---|---|---|---|---|---|
02/28/1992 | 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 |
---|---|---|---|---|---|
04/30/2021 | SUPPL-24 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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05/09/2016 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
08/30/2001 | SUPPL-22 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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12/13/1996 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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08/16/1996 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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10/03/1995 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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10/03/1995 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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10/03/1995 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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11/20/1995 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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11/20/1995 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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11/20/1995 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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03/02/1995 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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01/26/1994 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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01/26/1994 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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01/26/1994 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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01/26/1994 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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01/26/1994 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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01/26/1994 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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07/28/1995 | SUPPL-4 | Labeling |
Label is not available on this site. |
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04/01/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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04/01/1993 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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05/24/1993 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |