Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016110
Company: APOTHECON
Company: APOTHECON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROLIXIN ENANTHATE | FLUPHENAZINE ENANTHATE | 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 03/15/1967 | ORIG-1 | Approval | Type 2 - New Active Ingredient | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/21/1992 | SUPPL-37 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 04/26/1989 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/19/1986 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/13/1986 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/30/1985 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/21/1982 | SUPPL-29 | Labeling |
Label is not available on this site. |
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| 02/04/1982 | SUPPL-28 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 09/11/1981 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/31/1981 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 05/14/1981 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/23/1981 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/09/1981 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 01/04/1980 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/18/1979 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 12/15/1978 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/08/1977 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |