Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085787
Company: FOSUN PHARMA
Company: FOSUN PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRIFLUOPERAZINE HYDROCHLORIDE | TRIFLUOPERAZINE HYDROCHLORIDE | EQ 10MG BASE/ML | CONCENTRATE;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 |
|---|---|---|---|---|---|---|---|
| 04/15/1982 | 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 |
|---|---|---|---|---|---|
| 03/19/2015 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/24/1994 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/29/1992 | SUPPL-29 | Labeling |
Label is not available on this site. |
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| 09/15/1989 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 10/10/1989 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 03/16/1988 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/16/1988 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/30/1986 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/03/1984 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/02/1984 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/13/1984 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/01/1984 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/19/1983 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/09/1982 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/09/1982 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/09/1982 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/22/1982 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/28/1982 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |