Drugs@FDA: FDA-Approved Drugs
Company: KEY THERAP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FENOPROFEN CALCIUM | FENOPROFEN CALCIUM | EQ 600MG BASE | 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 |
---|---|---|---|---|---|---|---|
06/08/1988 | 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-25 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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05/09/2016 | SUPPL-23 | Labeling-Medication Guide |
Label is not available on this site. |
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04/24/2015 | SUPPL-22 | Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
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12/20/2007 | SUPPL-19 | Labeling |
Label is not available on this site. |
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05/16/2006 | SUPPL-16 | Labeling |
Label is not available on this site. |
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03/13/2006 | SUPPL-15 | Labeling |
Label is not available on this site. |
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02/05/1998 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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06/26/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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03/04/1997 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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10/09/1991 | SUPPL-9 | Labeling |
Label is not available on this site. |
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10/31/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
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10/31/1991 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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01/31/1990 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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08/11/1988 | SUPPL-3 | Labeling |
Label is not available on this site. |