Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076287
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 05/20/2008 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/076287s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/18/2023 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/20/2021 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/04/2017 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/05/2016 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/31/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/22/2010 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/14/2009 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 01/26/2009 | SUPPL-2 | Labeling |
Label is not available on this site. |