Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078139
Company: MYLAN
Company: MYLAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ONDANSETRON | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | No | No |
ONDANSETRON | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING;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 |
---|---|---|---|---|---|---|---|
06/25/2007 | 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 |
---|---|---|---|---|---|
01/31/2023 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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01/31/2023 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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03/07/2018 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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03/31/2017 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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12/07/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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08/27/2013 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |