Application 200477
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| 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 |
| 004 | RISEDRONATE SODIUM | RISEDRONATE SODIUM | TABLET;ORAL | 75MG | No | No |
| 005 | RISEDRONATE SODIUM | RISEDRONATE SODIUM | TABLET;ORAL | 150MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-4044 | Risedronate Sodium | risedronate sodium | Mylan Pharmaceuticals Inc | ANDA | Current |
| 0378-4114 | Risedronate Sodium | risedronate sodium | Mylan Pharmaceuticals Inc | ANDA | Current |
| 0378-4150 | Risedronate Sodium | risedronate sodium | Mylan Pharmaceuticals Inc | ANDA | Current |
| 0378-4150 | Risedronate Sodium | risedronate sodium | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4714 | Risedronate Sodium | risedronate sodium | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4714 | Risedronate Sodium | risedronate sodium | Mylan Pharmaceuticals Inc | ANDA | Current |
| 0378-4714 | Risedronate Sodium | risedronate sodium | Mylan Pharmaceuticals Inc. | ANDA | Current |