Application 214348
- Type
- ANDA
- Sponsor
- HENGRUI PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUPIVACAINE LIPOSOME | BUPIVACAINE | INJECTABLE, LIPOSOMAL;INJECTION | 133MG/10ML (13.3MG/ML) | No | No |
| 002 | BUPIVACAINE LIPOSOME | BUPIVACAINE | INJECTABLE, LIPOSOMAL;INJECTION | 266MG/20ML (13.3MG/ML) | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79301 | ORIG | 2024-08-02 |