Application 021640
- Type
- BLA
- Sponsor
- BAUSCH AND LOMB
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VITRASE | HYALURONIDASE | INJECTABLE;INJECTION | 6,200 UNITS/VIAL | No | No |
| 002 | VITRASE | HYALURONIDASE | INJECTABLE;INJECTION | 200 UNITS/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 24208-002 | VITRASE | hyaluronidase, ovine | Bausch & Lomb Incorporated | BLA | Current |
| 24208-002 | VITRASE | hyaluronidase, ovine | Bausch & Lomb Incorporated | NDA | Current |
| 24208-002 | VITRASE | hyaluronidase, ovine | Bausch & Lomb Incorporated | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 77226 | SUPPL | 2024-01-16 |
| 77216 | SUPPL | 2024-01-16 |
| 62382 | APPL | 2020-03-31 |
| 54376 | SUPPL | 2020-03-23 |
| 54371 | SUPPL | 2020-03-23 |
| 44482 | ORIG | 2020-03-23 |
| 37380 | SUPPL | 2020-03-23 |
| 37379 | SUPPL | 2020-03-23 |
| 37378 | SUPPL | 2020-03-23 |
| 37377 | SUPPL | 2020-03-23 |
| 37376 | ORIG | 2020-03-23 |
| 28293 | SUPPL | 2020-03-23 |
| 28292 | SUPPL | 2020-03-23 |
| 28291 | SUPPL | 2020-03-23 |
| 28290 | ORIG | 2020-03-23 |
| 21764 | ORIG | 2020-03-23 |
| 5899 | SUPPL | 2020-03-23 |