Drugs@FDA: FDA-Approved Drugs
Company: ENDO OPERATIONS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IBUPROFEN | IBUPROFEN | 400MG | 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 |
---|---|---|---|---|---|---|---|
10/22/1986 | 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-19 | Labeling-Package Insert |
Label is not available on this site. |
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07/22/2019 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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05/09/2016 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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12/05/1997 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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02/24/1997 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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06/22/1995 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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01/12/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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06/02/1992 | SUPPL-12 | Labeling |
Label is not available on this site. |
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12/14/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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11/29/1990 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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06/28/1989 | SUPPL-9 | Labeling |
Label is not available on this site. |
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12/30/1988 | SUPPL-7 | Labeling |
Label is not available on this site. |
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01/13/1989 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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10/11/1988 | SUPPL-5 | Labeling |
Label is not available on this site. |
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01/13/1989 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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08/27/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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08/27/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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07/30/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |