Application 077303
- Type
- ANDA
- Sponsor
- CHARTWELL MOLECULES
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | TABLET;ORAL | EQ 4MG BASE | No | No |
| 002 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | TABLET;ORAL | EQ 8MG BASE | No | No |
| 003 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | TABLET; ORAL | 16MG | No | No |
| 004 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | TABLET;ORAL | EQ 24MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 62135-350 | ONDANSETRON | ONDANSETRON | Chartwell RX, LLC | ANDA | Current |
| 62135-350 | ONDANSETRON | ONDANSETRON | Chartwell RX, LLC | ANDA | Current |
| 62135-351 | ONDANSETRON | ONDANSETRON | Chartwell RX, LLC | ANDA | Current |
| 62135-351 | ONDANSETRON | ONDANSETRON | Chartwell RX, LLC | ANDA | Current |