Application 761127
- Type
- BLA
- Sponsor
- REVANCE THERAPEUTICS, INC.
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DAXXIFY | daxibotulinumtoixnA-lanm | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 0.1ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 72960-112 | DAXXIFY | botulinum toxin type A | Revance Therapeutics, Inc. | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 75081 | SUPPL | 2023-08-16 |
| 75080 | SUPPL | 2023-08-16 |
| 75061 | SUPPL | 2023-08-14 |
| 72258 | ORIG | 2022-10-06 |
| 72051 | ORIG | 2022-09-09 |
| 72050 | ORIG | 2022-09-09 |
| 72047 | ORIG | 2022-09-08 |