Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016008
Company: SCHERING
Company: SCHERING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PERMITIL | FLUPHENAZINE HYDROCHLORIDE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CONCENTRATE;ORAL | Discontinued | None | No | No |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 |
---|---|---|---|---|---|---|---|
04/07/1965 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
07/26/1999 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/13/1989 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/13/1989 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/04/1988 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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05/19/2000 | SUPPL-13 | Labeling |
Label is not available on this site. |
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09/11/1986 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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07/28/1989 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/26/1987 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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04/19/1982 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |