Application 021665
- Type
- BLA
- Sponsor
- AMPHASTAR PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMPHADASE | HYALURONIDASE | INJECTABLE;INJECTION | 150 UNITS/ML | No | No |
NDC Listings For This Application#
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79513 | SUPPL | 2024-09-02 |
| 79501 | SUPPL | 2024-08-29 |
| 62336 | APPL | 2020-03-25 |
| 42262 | ORIG | 2020-03-23 |
| 37427 | SUPPL | 2020-03-23 |
| 37426 | SUPPL | 2020-03-23 |
| 28337 | SUPPL | 2020-03-23 |
| 28336 | SUPPL | 2020-03-23 |
| 28335 | ORIG | 2020-03-23 |
| 15947 | SUPPL | 2020-03-23 |
| 15946 | ORIG | 2020-03-23 |
| 5949 | SUPPL | 2020-03-23 |