Drugs@FDA: FDA-Approved Drugs
Company: APOTHECON
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROLIXIN | FLUPHENAZINE HYDROCHLORIDE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
PROLIXIN | FLUPHENAZINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
PROLIXIN | FLUPHENAZINE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
PROLIXIN | FLUPHENAZINE HYDROCHLORIDE | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
PROLIXIN | FLUPHENAZINE HYDROCHLORIDE | 2.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |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 |
---|---|---|---|---|---|---|---|
08/24/1960 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
---|---|---|---|---|---|
09/30/2002 | SUPPL-99 | Manufacturing (CMC) |
Label is not available on this site. |
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08/08/1997 | SUPPL-98 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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08/08/1997 | SUPPL-97 | Manufacturing (CMC) |
Label is not available on this site. |
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05/30/1997 | SUPPL-95 | Labeling |
Label is not available on this site. |
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12/20/1994 | SUPPL-93 | Labeling |
Label is not available on this site. |
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06/28/1991 | SUPPL-92 | Labeling |
Label is not available on this site. |
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06/28/1991 | SUPPL-91 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/13/2009 | SUPPL-90 | Labeling |
Label is not available on this site. |
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03/13/2009 | SUPPL-89 | Labeling |
Label is not available on this site. |
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03/13/2009 | SUPPL-88 | Labeling |
Label is not available on this site. |
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03/13/2009 | SUPPL-87 | Labeling |
Label is not available on this site. |
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03/13/2009 | SUPPL-84 | Labeling |
Label is not available on this site. |
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03/13/2009 | SUPPL-82 | Labeling |
Label is not available on this site. |
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08/02/1985 | SUPPL-79 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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03/13/2009 | SUPPL-77 | Labeling |
Label is not available on this site. |
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03/13/2009 | SUPPL-76 | Labeling |
Label is not available on this site. |
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03/13/2009 | SUPPL-65 | Labeling |
Label is not available on this site. |
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03/13/2009 | SUPPL-64 | Labeling |
Label is not available on this site. |
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03/13/2009 | SUPPL-61 | Labeling |
Label is not available on this site. |
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03/13/2009 | SUPPL-59 | Labeling |
Label is not available on this site. |
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03/13/2009 | SUPPL-58 | Labeling |
Label is not available on this site. |
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03/13/2009 | SUPPL-56 | Labeling |
Label is not available on this site. |
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03/13/2009 | SUPPL-55 | Labeling |
Label is not available on this site. |
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03/13/2009 | SUPPL-54 | Labeling |
Label is not available on this site. |
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04/23/1979 | SUPPL-52 | Labeling |
Label is not available on this site. |
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03/13/2009 | SUPPL-49 | Labeling |
Label is not available on this site. |
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03/13/2009 | SUPPL-48 | Labeling |
Label is not available on this site. |
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02/06/1979 | SUPPL-47 | Labeling |
Label is not available on this site. |
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03/13/2009 | SUPPL-46 | Labeling |
Label is not available on this site. |
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03/13/2009 | SUPPL-45 | Labeling |
Label is not available on this site. |
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03/13/2009 | SUPPL-30 | Labeling |
Label is not available on this site. |
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03/13/2009 | SUPPL-29 | Labeling |
Label is not available on this site. |
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03/13/2009 | SUPPL-28 | Labeling |
Label is not available on this site. |
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03/13/2009 | SUPPL-27 | Labeling |
Label is not available on this site. |
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03/13/2009 | SUPPL-25 | Labeling |
Label is not available on this site. |
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03/13/2009 | SUPPL-23 | Labeling |
Label is not available on this site. |