Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074031
Company: PHARMOBEDIENT
Company: PHARMOBEDIENT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRIAZOLAM | TRIAZOLAM | 0.125MG | TABLET;ORAL | Discontinued | None | No | No |
| TRIAZOLAM | TRIAZOLAM | 0.25MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/25/1994 | 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 |
|---|---|---|---|---|---|
| 09/18/2008 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 03/18/2004 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 03/27/1997 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 07/06/1994 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |