Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078791
Company: IMPAX LABS
Company: IMPAX LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | 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 |
|---|---|---|---|---|---|---|---|
| 05/06/2009 | 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 |
|---|---|---|---|---|---|
| 01/21/2020 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/21/2020 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/21/2020 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/21/2020 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/21/2020 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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| 02/16/2016 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/04/2009 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 08/04/2009 | SUPPL-1 |
Label is not available on this site. |