| NDC Code | 70842-102-03 |
|---|
| Package Description | 10 VIAL, GLASS in 1 CARTON (70842-102-03) / 10.5 mL in 1 VIAL, GLASS (70842-102-01) |
|---|
| Product NDC | 70842-102 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Baxdela |
|---|
| Non-Proprietary Name | Delafloxacin Meglumine |
|---|
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
|---|
| Usage | INTRAVENOUS |
|---|
| Start Marketing Date | 20170619 |
|---|
| Marketing Category Name | NDA |
|---|
| Application Number | NDA208611 |
|---|
| Manufacturer | Melinta Therapeutics, LLC |
|---|
| Substance Name | DELAFLOXACIN MEGLUMINE |
|---|
| Strength | 300 |
|---|
| Strength Unit | mg/10.5mL |
|---|
| Pharmacy Classes | Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS] |
|---|