Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203240
Company: TORRENT
Company: TORRENT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
FLUVOXAMINE MALEATE | FLUVOXAMINE MALEATE | 150MG | CAPSULE, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
10/31/2014 | 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 |
---|---|---|---|---|---|
08/18/2023 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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08/10/2023 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |