Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078127
Company: PHARM ASSOC
Company: PHARM ASSOC
| 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 |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 04/03/2026 | SUPPL-14 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/17/2025 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/17/2025 | SUPPL-11 | 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. |
||
| 03/27/2017 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/15/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/15/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/15/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/29/2013 | SUPPL-4 | Labeling-Container/Carton Labels, 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 |