Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 083040
Company: FOSUN PHARMA
Company: FOSUN PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SONAZINE | CHLORPROMAZINE HYDROCHLORIDE | 10MG/5ML | SYRUP;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 |
|---|---|---|---|---|---|---|---|
| 03/04/1976 | 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 |
|---|---|---|---|---|---|
| 02/05/2020 | SUPPL-44 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/23/2017 | SUPPL-43 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/01/2012 | SUPPL-42 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/24/1994 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/04/1992 | SUPPL-40 | Labeling |
Label is not available on this site. |
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| 06/14/1990 | SUPPL-39 | Labeling |
Label is not available on this site. |
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| 09/12/1989 | SUPPL-35 | Labeling |
Label is not available on this site. |
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| 08/04/1988 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/04/1988 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/04/1988 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/19/1988 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 05/29/1986 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/11/1985 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/06/1983 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/08/1983 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/24/1982 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/19/1982 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/19/1982 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/19/1982 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |