Application 210282
- Type
- NDA
- Sponsor
- HOSPIRA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DAPTOMYCIN | DAPTOMYCIN | POWDER;INTRAVENOUS, SUBCUTANEOUS | 350MG/VIAL | Yes | No |
| 002 | DAPTOMYCIN | DAPTOMYCIN | POWDER;INTRAVENOUS, SUBCUTANEOUS | 500MG/VIAL | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0409-0120 | Daptomycin | DAPTOMYCIN | Hospira, Inc. | NDA | Current |
| 0409-0120 | Daptomycin | DAPTOMYCIN | Hospira, Inc. | NDA | Current |
| 0409-0120 | Daptomycin | DAPTOMYCIN | Hospira, Inc. | NDA | Current |
| 0409-0122 | Daptomycin | DAPTOMYCIN | Hospira, Inc. | NDA | Current |
| 0409-0122 | Daptomycin | DAPTOMYCIN | Hospira, Inc. | NDA | Current |
| 0409-0122 | Daptomycin | DAPTOMYCIN | Hospira, Inc. | NDA | Current |