Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089804
Company: PRASCO
Company: PRASCO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Discontinued | None | No | No |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 1MG | TABLET;ORAL | Discontinued | None | No | No |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Discontinued | None | No | No |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 5MG | 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 |
|---|---|---|---|---|---|---|---|
| 08/12/1988 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/23/2017 | SUPPL-20 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/03/2010 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 05/26/2009 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 09/18/2008 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 08/19/2008 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 12/21/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/05/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/10/1995 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 05/10/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/10/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/07/1993 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/11/1993 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/31/1990 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |