Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012145
Company: APOTHECON
Company: APOTHECON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROLIXIN | FLUPHENAZINE HYDROCHLORIDE | 2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ELIXIR;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 12/23/1959 | 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 |
|---|---|---|---|---|---|
| 07/12/2002 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 02/06/1979 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-7 | Labeling |
Label is not available on this site. |