Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090469
Company: AUROBINDO PHARMA
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. |
||
| 01/31/2024 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/07/2018 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/27/2017 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/27/2017 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/21/2014 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/21/2014 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/16/2012 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 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 | 078139 | MYLAN |
| 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 | 078139 | MYLAN |
| 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 |