Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077517
Company: CASI PHARMS INC
Company: CASI PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 06/25/2007 | 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 |
|---|---|---|---|---|---|
| 03/08/2018 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/15/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/15/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/30/2012 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/12/2013 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 06/25/2007 | SUPPL-2 |
Label is not available on this site. |
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| 06/25/2007 | SUPPL-1 |
Label is not available on this site. |