Drugs@FDA: FDA-Approved Drugs
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | 25MG | TABLET;ORAL | Discontinued | None | No | No |
| FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | 50MG | TABLET;ORAL | Discontinued | None | No | No |
| FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/25/2001 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75897ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/18/2023 | SUPPL-26 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/10/2023 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/07/2013 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/29/2012 | SUPPL-22 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 05/16/2012 | SUPPL-21 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 04/15/2009 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 10/16/2007 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 06/29/2007 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 02/21/2007 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 03/09/2006 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 05/03/2005 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 10/26/2004 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 05/18/2004 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 12/16/2003 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 12/23/2002 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/23/2002 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/10/2002 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 07/17/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/17/2002 | SUPPL-2 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 08/01/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |