Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090116
Company: CHARTWELL MOLECULAR
Company: CHARTWELL MOLECULAR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ONDANSETRON HYDROCHLORIDE | 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 |
|---|---|---|---|---|---|---|---|
| 04/14/2010 | 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 |
|---|---|---|---|---|---|
| 04/19/2023 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/19/2023 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/02/2016 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/02/2016 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/16/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/08/2013 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/10/2012 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/30/2011 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/22/2011 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |