Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077406
Company: CHARTWELL MOLECULES
Company: CHARTWELL MOLECULES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ONDANSETRON | ONDANSETRON | 16MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | None | No | Yes |
ONDANSETRON | ONDANSETRON | 24MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | None | No | Yes |
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 |
---|---|---|---|---|---|---|---|
12/26/2006 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077406s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/26/2018 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
09/28/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
01/04/2008 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
10/31/2007 | SUPPL-3 | Labeling |
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 |