Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074060
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VALPROIC ACID | VALPROIC ACID | 250MG/5ML | SYRUP;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 |
|---|---|---|---|---|---|---|---|
| 01/13/1995 | 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 |
|---|---|---|---|---|---|
| 03/11/2020 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/11/2020 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/11/2020 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/11/2020 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/11/2020 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/01/2015 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/01/2015 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/01/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/01/2015 | SUPPL-10 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/01/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/01/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/01/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/01/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/12/2010 | SUPPL-3 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 07/05/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |