Drugs@FDA: FDA-Approved Drugs
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
INDOMETHACIN | INDOMETHACIN | 25MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
03/18/1987 | 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 |
---|---|---|---|---|---|
04/28/2021 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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04/17/2021 | SUPPL-19 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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05/09/2016 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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08/13/2002 | SUPPL-15 | Labeling |
Label is not available on this site. |
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06/05/2001 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/07/2000 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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07/02/1996 | SUPPL-12 | Labeling |
Label is not available on this site. |
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04/29/1996 | SUPPL-11 | Labeling |
Label is not available on this site. |
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07/15/1994 | SUPPL-10 | Labeling |
Label is not available on this site. |
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05/11/1994 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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11/08/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
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04/01/1991 | SUPPL-6 | Labeling |
Label is not available on this site. |
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02/24/1989 | SUPPL-5 | Labeling |
Label is not available on this site. |
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02/08/1989 | SUPPL-4 | Labeling |
Label is not available on this site. |
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11/23/1992 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |