Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075910
Company: ACTAVIS ELIZABETH
Company: ACTAVIS ELIZABETH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DICLOFENAC SODIUM | DICLOFENAC SODIUM | 100MG | TABLET, EXTENDED 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 |
---|---|---|---|---|---|---|---|
01/07/2002 | 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 |
---|---|---|---|---|---|
09/12/2024 | SUPPL-30 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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04/28/2021 | SUPPL-28 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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03/29/2021 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
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10/26/2014 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
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05/13/2009 | SUPPL-16 | Labeling |
Label is not available on this site. |
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07/28/2006 | SUPPL-9 | Labeling |
Label is not available on this site. |
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07/11/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |