Drugs@FDA: FDA-Approved Drugs
Company: ROXANE
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 |
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 75MG | 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 |
---|---|---|---|---|---|---|---|
06/29/1995 | 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 |
---|---|---|---|---|---|
09/22/2006 | SUPPL-12 | Labeling |
Label is not available on this site. |
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11/09/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/09/2001 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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11/09/2001 | SUPPL-9 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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11/09/2001 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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01/08/2002 | SUPPL-7 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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01/08/2002 | SUPPL-6 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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01/08/2002 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/09/2001 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/09/2001 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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12/22/1999 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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08/28/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |