Application 209511
- Type
- NDA
- Sponsor
- INNOCOLL PHARMACEUTICALS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | XARACOLL | BUPIVACAINE HCI | IMPLANT;SUBCUTANEOUS | 300MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 51715-100 | XARACOLL | Bupivacaine HCl Collagen-matrix | INNOCOLL PHARMACEUTICALS | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 68163 | ORIG | 2021-07-22 |
| 64482 | ORIG | 2020-09-02 |
| 64460 | ORIG | 2020-09-01 |