Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077343
Company: APOTEX INC
Company: APOTEX INC
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 |
---|---|---|---|---|---|
03/15/2022 | SUPPL-11 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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08/16/2021 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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08/16/2021 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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12/31/2014 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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12/31/2014 | SUPPL-7 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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12/31/2014 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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06/19/2007 | SUPPL-2 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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06/14/2007 | SUPPL-1 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |