Drugs@FDA: FDA-Approved Drugs
Company: ANI PHARMS
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 |
---|---|---|---|---|---|---|---|
05/02/1988 | 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-Package Insert |
Label is not available on this site. |
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05/09/2016 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
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02/18/2016 | SUPPL-23 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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03/08/2002 | SUPPL-14 | Labeling |
Label is not available on this site. |
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02/26/2002 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/02/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/07/1999 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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01/18/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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05/13/1994 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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07/22/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
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07/29/1991 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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01/04/1989 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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01/04/1989 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |