Application 761385
- Type
- BLA
- Sponsor
- TEVA PHARMACEUTICALS, INC.
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761385 | Ponlimsi | denosumab-adet | 351(k) Interchangeable | Rx | 2026-06-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PONLIMSI | DENOSUMAB-ADET | INJECTABLE;SUBCUTANEOUS | 60MG/ML | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85611 | ORIG | 2026-03-31 |
| 85574 | ORIG | 2026-03-30 |