Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075898
Company: ANI PHARMS
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 |
|---|---|---|---|---|---|---|---|
| 03/12/2001 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75898ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/18/2023 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/10/2023 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/29/2008 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 09/14/2007 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 06/27/2007 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 08/29/2006 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 11/29/2005 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 06/09/2005 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 11/02/2004 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 10/21/2002 | SUPPL-4 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 11/20/2002 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/30/2001 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 10/30/2001 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |