Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075889
Company: MYLAN
Company: MYLAN
| 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 |
|---|---|---|---|---|---|---|---|
| 11/29/2000 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75889ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/18/2023 | SUPPL-31 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 08/10/2023 | SUPPL-30 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/10/2023 | SUPPL-26 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/08/2015 | SUPPL-24 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/04/2009 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 10/16/2007 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 06/29/2007 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 07/24/2006 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 06/09/2005 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 04/14/2005 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 06/18/2004 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 05/11/2004 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 03/24/2004 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 08/29/2003 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 02/05/2003 | SUPPL-1 | Labeling |
Label is not available on this site. |