Application 213645
- Type
- NDA
- Sponsor
- BAXTER HLTHCARE CORP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DAPZURA RT | DAPTOMYCIN | INJECTABLE;INJECTION | 500MG | No | No |
| 002 | DAPTOMYCIN IN 0.9% SODIUM CHLORIDE | DAPTOMYCIN | SOLUTION;INTRAVENOUS | 350MG/50ML (7MG/ML) | Yes | Yes |
| 003 | DAPTOMYCIN IN 0.9% SODIUM CHLORIDE | DAPTOMYCIN | SOLUTION;INTRAVENOUS | 500MG/50ML (10MG/ML) | Yes | Yes |
| 004 | DAPTOMYCIN IN 0.9% SODIUM CHLORIDE | DAPTOMYCIN | SOLUTION;INTRAVENOUS | 700MG/100ML (7MG/ML) | Yes | Yes |
| 005 | DAPTOMYCIN IN 0.9% SODIUM CHLORIDE | DAPTOMYCIN | SOLUTION;INTRAVENOUS | 1GM/100ML (10MG/ML) | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 60977-145 | DAPZURA RT | daptomycin | Baxter Healthcare Corporation | NDA | Current |
| 60977-145 | DAPZURA RT | daptomycin | Baxter Healthcare Corporation | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 82146 | SUPPL | 2025-05-05 |
| 82287 | SUPPL | 2025-04-30 |
| 73626 | SUPPL | 2023-02-28 |
| 73620 | SUPPL | 2023-02-28 |
| 71865 | ORIG | 2022-08-23 |
| 69980 | ORIG | 2022-01-27 |
| 69978 | ORIG | 2022-01-27 |