Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012034
Company: SCHERING
Company: SCHERING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PERMITIL | FLUPHENAZINE HYDROCHLORIDE | 0.25MG | TABLET;ORAL | Discontinued | None | No | No |
| PERMITIL | FLUPHENAZINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Discontinued | None | No | No |
| PERMITIL | FLUPHENAZINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Discontinued | None | No | No |
| PERMITIL | FLUPHENAZINE HYDROCHLORIDE | 10MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 09/09/1959 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 10/18/1999 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/19/2000 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 11/12/2002 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 11/12/2002 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 11/12/2002 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 11/12/2002 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 11/12/2002 | SUPPL-4 | Labeling |
Label is not available on this site. |
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