Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202600
Company: EUGIA PHARMA
Company: EUGIA PHARMA
| 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 |
|---|---|---|---|---|---|---|---|
| 12/21/2012 | 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 |
|---|---|---|---|---|---|
| 09/26/2023 | SUPPL-13 |
Label is not available on this site. |
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| 03/01/2022 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/19/2021 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/19/2021 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/09/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/09/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |