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. |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English