Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209389
Company: IPCA LABS LTD
Company: IPCA LABS LTD
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 | 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 |
---|---|---|---|---|---|---|---|
10/30/2023 | ORIG-1 | Approval | STANDARD |
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 |