Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076252
Company: TEVA
Company: TEVA
| 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 |
|---|---|---|---|---|---|
| 05/14/2018 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/19/2014 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/19/2014 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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| 02/13/2012 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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| 11/30/2010 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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| 10/31/2007 | SUPPL-2 | Labeling |
Label is not available on this site. |