Application 090797
- Type
- ANDA
- Sponsor
- ACTAVIS TOTOWA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | TABLET, DELAYED RELEASE;ORAL | EQ 20MG BASE | No | No |
| 002 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | TABLET, DELAYED RELEASE;ORAL | EQ 40MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 53808-0957 | Pantoprazole Sodium | Pantoprazole Sodium | State of Florida DOH Central Pharmacy | ANDA | Current |
| 63187-042 | Pantoprazole Sodium | Pantoprazole Sodium | Proficient Rx LP | ANDA | Current |
| 63187-042 | Pantoprazole Sodium | Pantoprazole Sodium | Proficient Rx LP | ANDA | Current |