Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075899
Company: SYNTHON PHARMS
Company: SYNTHON 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 |
|---|---|---|---|---|---|---|---|
| 01/17/2001 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75899ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/16/2007 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 06/29/2007 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 10/18/2006 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 07/08/2005 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 04/14/2005 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 04/14/2005 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 11/20/2004 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 09/25/2003 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 07/24/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |