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Application 208743
- Type
- NDA
- Sponsor
- RADIUS HEALTH INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TYMLOS | ABALOPARATIDE | SOLUTION;SUBCUTANEOUS | 3.12MG/1.56ML (2MG/ML) | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 70539-001 | Tymlos | abaloparatide | Radius Health, Inc. | NDA | Current |
| 70539-001 | Tymlos | abaloparatide | Radius Health, Inc. | NDA | Current |
| 70539-001 | Tymlos | abaloparatide | Radius Health, Inc. | NDA | Current |
| 70539-001 | Tymlos | abaloparatide | Radius Health, Inc. | NDA | Current |
| 70539-001 | Tymlos | abaloparatide | Radius Health, Inc. | NDA | Current |
| 70539-001 | Tymlos | abaloparatide | Radius Health, Inc. | NDA | Current |
| 70539-001 | Tymlos | abaloparatide | Radius Health, Inc. | NDA | Current |
| 70539-001 | Tymlos | abaloparatide | Radius Health, Inc. | NDA | Current |