Drugs@FDA: FDA-Approved Drugs
Company: UPSHER SMITH LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VALPROIC ACID | VALPROIC ACID | 250MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 06/11/1987 | 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 |
|---|---|---|---|---|---|
| 02/28/2001 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 12/15/1997 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 12/15/1997 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/15/1997 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/15/1997 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/15/1997 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/16/1995 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/16/1995 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/31/1993 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/31/1993 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/31/1993 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/31/1993 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/31/1993 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/11/1993 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 02/12/1992 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 01/25/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 11/16/1990 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/06/1989 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/06/1989 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/06/1989 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |