Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077391
Company: PHARMOBEDIENT
Company: PHARMOBEDIENT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALPRAZOLAM | ALPRAZOLAM | 3MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| ALPRAZOLAM | ALPRAZOLAM | 0.5MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| ALPRAZOLAM | ALPRAZOLAM | 1MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| ALPRAZOLAM | ALPRAZOLAM | 2MG | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 01/26/2006 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077391ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/13/2025 | SUPPL-12 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 03/13/2025 | SUPPL-10 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/08/2013 | SUPPL-7 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |