Application 203533
- Type
- ANDA
- Sponsor
- MACLEODS PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RISEDRONATE SODIUM | RISEDRONATE SODIUM | TABLET;ORAL | 5MG | No | No |
| 002 | RISEDRONATE SODIUM | RISEDRONATE SODIUM | TABLET;ORAL | 30MG | No | No |
| 003 | RISEDRONATE SODIUM | RISEDRONATE SODIUM | TABLET;ORAL | 35MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 33342-107 | Risedronate Sodium | Risedronate Sodium | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-107 | Risedronate Sodium | Risedronate Sodium | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-107 | Risedronate Sodium | Risedronate Sodium | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-107 | Risedronate Sodium | Risedronate Sodium | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-108 | Risedronate Sodium | Risedronate Sodium | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-108 | Risedronate Sodium | Risedronate Sodium | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-108 | Risedronate Sodium | Risedronate Sodium | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-108 | Risedronate Sodium | Risedronate Sodium | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-109 | Risedronate Sodium | Risedronate Sodium | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-109 | Risedronate Sodium | Risedronate Sodium | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-109 | Risedronate Sodium | Risedronate Sodium | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-109 | Risedronate Sodium | Risedronate Sodium | Macleods Pharmaceuticals Limited | ANDA | Current |