Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070868
Company: PHARMOBEDIENT CNSLTG
Company: PHARMOBEDIENT CNSLTG
| 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 |
|---|---|---|---|---|---|---|---|
| 07/01/1986 | 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 |
|---|---|---|---|---|---|
| 03/31/2026 | SUPPL-23 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 01/06/2010 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/15/2006 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 03/10/2004 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 03/21/2003 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 05/24/2002 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 05/04/1999 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/04/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/24/1993 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 01/11/1989 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 06/15/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/13/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/10/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |