Application 225554
- Type
- BLA
- Sponsor
- BRISTOL-MYERS SQUIBB
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OPDIVO | NIVOLUMAB | INJECTABLE;INJECTION, SOLUTION | 40MG/4ML | No | No |
| 002 | OPDIVO | NIVOLUMAB | INJECTABLE;INJECTION, SOLUTION | 100MG/10ML | No | No |
| 003 | OPDIVO | NIVOLUMAB | INJECTABLE;INJECTION, SOLUTION | 120MG/12ML | No | No |
| 004 | OPDIVO | NIVOLUMAB | INJECTABLE;INJECTION, SOLUTION | 240MG/124ML | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 70403 | ORIG | 2022-03-07 |