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 |
|---|---|---|---|---|---|
| 04/28/2021 | SUPPL-28 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/29/2021 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/26/2014 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/13/2009 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 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. |