Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078244
Company: STERISCIENCE SPECLTS
Company: STERISCIENCE SPECLTS
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 |
---|---|---|---|---|---|---|---|
04/23/2008 | 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 |
---|---|---|---|---|---|
05/01/2023 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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05/01/2023 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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10/26/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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08/30/2013 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |