Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078539
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 | TABLET;ORAL | Prescription | AB | No | No |
ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET;ORAL | Prescription | AB | No | No |
ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 24MG BASE | TABLET;ORAL | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
07/31/2007 | 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 |
---|---|---|---|---|---|
03/07/2018 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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03/07/2018 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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01/15/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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01/15/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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10/17/2011 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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01/04/2011 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
ONDANSETRON HYDROCHLORIDE
TABLET;ORAL; EQ 4MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 077306 | APOTEX |
ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 078539 | AUROBINDO PHARMA |
ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 077303 | CHARTWELL MOLECULES |
ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 076183 | DR REDDYS LABS LTD |
ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 077535 | GLENMARK PHARMS LTD |
ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 203761 | IPCA LABS LTD |
ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 077851 | NATCO PHARMA LTD |
ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 077050 | SUN PHARM INDS (IN) |
TABLET;ORAL; EQ 8MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET;ORAL | Prescription | No | AB | 077306 | APOTEX |
ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET;ORAL | Prescription | No | AB | 078539 | AUROBINDO PHARMA |
ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET;ORAL | Prescription | No | AB | 077303 | CHARTWELL MOLECULES |
ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET;ORAL | Prescription | No | AB | 076183 | DR REDDYS LABS LTD |
ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET;ORAL | Prescription | No | AB | 077535 | GLENMARK PHARMS LTD |
ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET;ORAL | Prescription | No | AB | 203761 | IPCA LABS LTD |
ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET;ORAL | Prescription | No | AB | 077851 | NATCO PHARMA LTD |
ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET;ORAL | Prescription | No | AB | 077050 | SUN PHARM INDS (IN) |