Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076780
Company: HIKMA FARMACEUTICA
Company: HIKMA FARMACEUTICA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | ONDANSETRON HYDROCHLORIDE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
12/26/2006 | 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 |
---|---|---|---|---|---|
04/26/2023 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
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04/26/2023 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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12/20/2014 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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12/20/2014 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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09/19/2013 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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04/30/2012 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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01/31/2011 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |