Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076125
Company: SUN PHARM INDUSTRIES
Company: SUN PHARM INDUSTRIES
| 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 |
|---|---|---|---|---|---|---|---|
| 04/29/2002 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/31/2023 | SUPPL-15 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 06/27/2007 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 05/12/2007 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 02/21/2007 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 07/24/2006 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 10/20/2004 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 02/13/2004 | SUPPL-3 | Labeling |
Label is not available on this site. |