Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019794
Company: ABBOTT
Company: ABBOTT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEPAKOTE CP | DIVALPROEX SODIUM | EQ 250MG BASE | TABLET, DELAYED RELEASE;ORAL | Discontinued | None | No | No |
| DEPAKOTE CP | DIVALPROEX SODIUM | EQ 500MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 07/11/1990 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/02/1996 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/23/1995 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |