Drugs@FDA: FDA-Approved Drugs
Company: CHARTWELL RX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 25MG | TABLET, DELAYED RELEASE;ORAL | Discontinued | None | No | No |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 50MG | TABLET, DELAYED RELEASE;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 |
---|---|---|---|---|---|---|---|
09/28/1995 | 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 |
---|---|---|---|---|---|
04/29/2021 | SUPPL-42 | Labeling-Package Insert |
Label is not available on this site. |
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03/30/2021 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
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05/09/2016 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
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11/26/2014 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
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04/09/2009 | SUPPL-31 | Labeling |
Label is not available on this site. |
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02/26/2009 | SUPPL-30 | Labeling |
Label is not available on this site. |
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01/16/2008 | SUPPL-25 | Labeling |
Label is not available on this site. |
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10/02/2006 | SUPPL-23 | Labeling |
Label is not available on this site. |
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09/05/2002 | SUPPL-19 | Labeling |
Label is not available on this site. |
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07/18/2002 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/25/2002 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/19/2002 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/09/2001 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/12/2002 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/12/2002 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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08/16/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/14/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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03/04/1999 | SUPPL-6 | Labeling |
Label is not available on this site. |
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03/04/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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01/28/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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06/13/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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06/10/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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09/16/1996 | SUPPL-1 | Labeling |
Label is not available on this site. |