Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076876
Company: TEVA
Company: TEVA
| 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 |
|---|---|---|---|---|---|---|---|
| 11/22/2006 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076876s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/076876s000LTR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/19/2014 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/19/2014 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/30/2013 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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| 02/10/2012 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |