Drugs@FDA: FDA-Approved Drugs
Company: STRIDES PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IBUPROFEN | IBUPROFEN | 800MG | 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 |
---|---|---|---|---|---|---|---|
07/25/1986 | 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-35 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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07/22/2019 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
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05/09/2016 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
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03/13/1998 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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01/14/1997 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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07/15/1994 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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04/08/1994 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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01/10/1992 | SUPPL-25 | Labeling |
Label is not available on this site. |
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06/11/1991 | SUPPL-24 | Labeling |
Label is not available on this site. |
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02/21/1989 | SUPPL-22 | Labeling |
Label is not available on this site. |
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12/30/1988 | SUPPL-21 | Labeling |
Label is not available on this site. |
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11/22/1988 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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03/02/1989 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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03/02/1989 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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07/01/1988 | SUPPL-16 | Labeling |
Label is not available on this site. |
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02/10/1988 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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09/22/1987 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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02/02/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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07/20/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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07/23/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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10/17/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |