Skip to contentApplication 090877
- Type
- ANDA
- Sponsor
- APOTEX INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RISEDRONATE SODIUM | RISEDRONATE SODIUM | TABLET;ORAL | 35MG | No | No |
| 002 | RISEDRONATE SODIUM | RISEDRONATE SODIUM | TABLET;ORAL | 75MG | No | No |
| 003 | RISEDRONATE SODIUM | RISEDRONATE SODIUM | TABLET;ORAL | 150MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 60505-3096 | Risedronate Sodium | Risedronate Sodium | Apotex Corp. | ANDA | Current |
| 60505-3096 | Risedronate Sodium | Risedronate Sodium | Apotex Corp. | ANDA | Current |
| 60505-3096 | Risedronate Sodium | Risedronate Sodium | Apotex Corp. | ANDA | Current |
| 60505-3097 | Risedronate Sodium | Risedronate Sodium | Apotex Corp. | ANDA | Current |
| 60505-3097 | Risedronate Sodium | Risedronate Sodium | Apotex Corp. | ANDA | Current |
| 60505-3097 | Risedronate Sodium | Risedronate Sodium | Apotex Corp. | ANDA | Current |
| 60505-3165 | Risedronate Sodium | Risedronate Sodium | Apotex Corp. | ANDA | Current |
| 60505-3165 | Risedronate Sodium | Risedronate Sodium | Apotex Corp. | ANDA | Current |
| 60505-3165 | Risedronate Sodium | Risedronate Sodium | Apotex Corp. | ANDA | Current |
| 71205-714 | Risedronate Sodium | Risedronate Sodium | Proficient Rx LP | ANDA | Current |