Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075281
Company: AUROBINDO PHARMA USA
Company: AUROBINDO PHARMA USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|
| 02/12/2002 | 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-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/29/2021 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/28/2014 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/19/2010 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/20/2007 | SUPPL-1 | Labeling |
Label is not available on this site. |