Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078945
Company: AVET LIFESCIENCES
Company: AVET LIFESCIENCES
| 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 |
|---|---|---|---|---|---|---|---|
| 01/03/2013 | 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 |
|---|---|---|---|---|---|
| 01/20/2023 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/18/2021 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/18/2021 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/14/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/14/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/14/2015 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |