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Application 212667
- Type
- ANDA
- Sponsor
- ACCORD HLTHCARE
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DAPTOMYCIN | DAPTOMYCIN | POWDER;IV (INFUSION) | 350MG/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16729-434 | Daptomycin | Daptomycin | Accord Healthcare, Inc. | ANDA | Current |
| 16729-434 | Daptomycin | Daptomycin | Accord Healthcare, Inc. | ANDA | Current |
| 16729-434 | Daptomycin | Daptomycin | Accord Healthcare, Inc. | ANDA | Current |
| 16729-434 | Daptomycin | Daptomycin | Accord Healthcare, Inc. | ANDA | Current |
| 16729-434 | Daptomycin | Daptomycin | Accord Healthcare, Inc. | ANDA | Current |
| 16729-434 | Daptomycin | Daptomycin | Accord Healthcare, Inc. | ANDA | Current |
| 68001-467 | Daptomycin | Daptomycin | BluePoint Laboratories | ANDA | Current |
| 68001-467 | Daptomycin | Daptomycin | BluePoint Laboratories | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 59612 | ORIG | 2019-08-07 |