Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070533
Company: APOTHECON
Company: APOTHECON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROLIXIN | FLUPHENAZINE HYDROCHLORIDE | 5MG/ML | CONCENTRATE;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 |
|---|---|---|---|---|---|---|---|
| 11/07/1985 | 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 |
|---|---|---|---|---|---|
| 03/04/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/16/1993 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/05/1987 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 10/05/1987 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 10/05/1987 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 03/10/1987 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 06/06/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/1986 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 03/20/1986 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 03/20/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |