Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071406
Company: MYLAN
Company: MYLAN
| 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 |
|---|---|---|---|---|---|---|---|
| 02/27/1991 | 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 |
|---|---|---|---|---|---|
| 03/25/2019 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/17/2014 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/05/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/14/1992 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 10/28/1991 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |