Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090514
Company: MYLAN PHARMS INC
Company: MYLAN PHARMS INC
| 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 |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 100MG | TABLET;ORAL | Discontinued | None | No | No |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 150MG | TABLET;ORAL | Discontinued | None | No | No |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 300MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/02/2009 | 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 |
|---|---|---|---|---|---|
| 05/18/2020 | SUPPL-6 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 07/17/2014 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/01/2014 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |