Application 761146
- Type
- BLA
- Sponsor
- ENDO GLOBAL AESTHETICS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | QWO | COLLAGENASE CLOSTRIDIUM HISTOLYTICUM-AAES | INJECTABLE;INJECTION | | No | No |
| 002 | QWO | COLLAGENASE CLOSTRIDIUM HISTOLYTICUM-AAES | SOLUTION;SUBCUTANEOUS | 1.84MG/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 73611-300 | Qwo | collagenase clostridium histolyticum-aaes | Endo Aesthetics LLC | BLA | Current |
| 73611-300 | Qwo | collagenase clostridium histolyticum | Endo Aesthetics LLC | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 66014 | ORIG | 2021-01-28 |
| 63822 | ORIG | 2020-07-08 |
| 63810 | ORIG | 2020-07-07 |