Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091483
Company: AMNEAL PHARMS
Company: AMNEAL PHARMS
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 |
---|---|---|---|---|---|---|---|
01/31/2011 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/14/2022 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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10/01/2021 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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03/07/2018 | SUPPL-5 | Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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02/07/2017 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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02/07/2017 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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04/27/2012 | SUPPL-2 | 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 |