Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 006800
Company: ABBVIE
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PARADIONE | PARAMETHADIONE | 300MG | CAPSULE;ORAL | Discontinued | None | No | No |
| PARADIONE | PARAMETHADIONE | 300MG/ML | SOLUTION;ORAL | Discontinued | None | No | No |
| PARADIONE | PARAMETHADIONE | 150MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/15/1949 | 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 |
|---|---|---|---|---|---|
| 03/24/1989 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/02/1987 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/07/1984 | SUPPL-13 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/28/1982 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/14/1980 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 10/24/1979 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/29/1975 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |