Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071636
Company: ALVOGEN
Company: ALVOGEN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 50MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/18/1988 | 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 |
|---|---|---|---|---|---|
| 06/09/2020 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/17/2014 | SUPPL-29 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/15/2005 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 01/06/2005 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 10/31/2002 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 11/02/2001 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/18/2000 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 09/12/2000 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 09/12/2000 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/12/2000 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/12/2000 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/12/2000 | SUPPL-9 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 11/22/1995 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 01/18/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/10/1995 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 04/28/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/30/1991 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 10/22/1991 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 09/30/1991 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |