Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078776
Company: AUROBINDO PHARMA
Company: AUROBINDO PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE/5ML | SOLUTION;ORAL | Prescription | AA | 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 |
|---|---|---|---|---|---|---|---|
| 11/28/2007 | 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 |
|---|---|---|---|---|---|
| 10/23/2025 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/23/2022 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/23/2022 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/07/2018 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/27/2017 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/08/2014 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/08/2014 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/13/2011 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/20/2011 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
ONDANSETRON HYDROCHLORIDE
SOLUTION;ORAL; EQ 4MG BASE/5ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 091483 | AMNEAL PHARMS |
| ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 078776 | AUROBINDO PHARMA |
| ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 091342 | CHARTWELL MOLECULAR |
| ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 076960 | HIKMA |
| ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE/5ML | SOLUTION;ORAL | Prescription | No | AA | 078127 | PHARM ASSOC |