Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 081310
Company: ANI PHARMS
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | 2.5MG/5ML | ELIXIR;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 |
---|---|---|---|---|---|---|---|
04/29/1993 | 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 |
---|---|---|---|---|---|
03/23/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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06/11/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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05/31/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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05/09/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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12/12/1994 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |