Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076960
Company: HIKMA
Company: HIKMA
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 | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/26/2006 | 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 |
---|---|---|---|---|---|
06/23/2022 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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06/23/2022 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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05/14/2018 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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05/14/2018 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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03/02/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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02/17/2012 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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10/13/2011 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
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11/30/2010 | 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 |