Drugs@FDA: FDA-Approved Drugs
Company: AUROBINDO PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ONDANSETRON | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | No | No |
ONDANSETRON | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
04/12/2010 | 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 |
---|---|---|---|---|---|
01/31/2024 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
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01/31/2024 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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03/07/2018 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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03/27/2017 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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03/27/2017 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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12/21/2014 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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12/21/2014 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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02/16/2012 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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12/08/2010 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
ONDANSETRON
TABLET, ORALLY DISINTEGRATING;ORAL; 4MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ONDANSETRON | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 090469 | AUROBINDO PHARMA |
ONDANSETRON | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077406 | CHARTWELL MOLECULES |
ONDANSETRON | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078152 | GLENMARK PHARMS LTD |
ONDANSETRON | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 209389 | IPCA LABS LTD |
ONDANSETRON | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078050 | SANDOZ |
ONDANSETRON | ONDANSETRON | 4MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077557 | SUN PHARM INDS |
TABLET, ORALLY DISINTEGRATING;ORAL; 8MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ONDANSETRON | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 090469 | AUROBINDO PHARMA |
ONDANSETRON | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077406 | CHARTWELL MOLECULES |
ONDANSETRON | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078152 | GLENMARK PHARMS LTD |
ONDANSETRON | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 209389 | IPCA LABS LTD |
ONDANSETRON | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 078050 | SANDOZ |
ONDANSETRON | ONDANSETRON | 8MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 077557 | SUN PHARM INDS |