Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 007707
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHENURONE | PHENACEMIDE | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 06/28/1951 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/07/1983 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/28/1983 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/17/1982 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 02/26/1980 | SUPPL-3 | Labeling |
Label is not available on this site. |