Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077009
Company: TARO
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE/5ML | SOLUTION;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 |
---|---|---|---|---|---|---|---|
11/30/2007 | 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 |
---|---|---|---|---|---|
04/23/2018 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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03/30/2017 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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12/20/2014 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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12/20/2014 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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04/27/2012 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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04/29/2011 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |