Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072483
Company: FOSUN PHARMA
Company: FOSUN PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/30/1990 | 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 |
|---|---|---|---|---|---|
| 04/28/2020 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/18/2014 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/09/2001 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/17/2001 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/30/2000 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 09/10/1999 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 09/10/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/03/1996 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 04/26/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/21/1992 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 12/09/1991 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |