Application 077406
- Type
- ANDA
- Sponsor
- CHARTWELL MOLECULES
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ONDANSETRON | ONDANSETRON | TABLET, ORALLY DISINTEGRATING;ORAL | 16MG | No | No |
| 002 | ONDANSETRON | ONDANSETRON | TABLET, ORALLY DISINTEGRATING;ORAL | 24MG | No | No |
| 003 | ONDANSETRON | ONDANSETRON | TABLET, ORALLY DISINTEGRATING;ORAL | 4MG | No | No |
| 004 | ONDANSETRON | ONDANSETRON | TABLET, ORALLY DISINTEGRATING;ORAL | 8MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 62135-121 | Ondansetron | Ondansetron | Chartwell RX, LLC | ANDA | Current |
| 62135-121 | Ondansetron | Ondansetron | Chartwell RX, LLC | ANDA | Current |
| 62135-122 | Ondansetron | Ondansetron | Chartwell RX, LLC | ANDA | Current |
| 62135-122 | Ondansetron | Ondansetron | Chartwell RX, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9040 | ORIG | 2007-01-08 |