Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076237
Company: BARR
Company: BARR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 90MG BASE | CAPSULE, DELAYED REL PELLETS;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 |
|---|---|---|---|---|---|---|---|
| 03/24/2010 | 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 |
|---|---|---|---|---|---|
| 08/18/2023 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/08/2021 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/08/2021 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/28/2012 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/28/2012 | SUPPL-3 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |