| NDC Code | 68083-174-10 |
|---|
| Package Description | 10 VIAL in 1 CARTON (68083-174-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (68083-174-01) |
|---|
| Product NDC | 68083-174 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Polymyxin B |
|---|
| Non-Proprietary Name | Polymyxin B Sulfate |
|---|
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
|---|
| Usage | INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC |
|---|
| Start Marketing Date | 20160601 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA207322 |
|---|
| Manufacturer | Gland Pharma Limited |
|---|
| Substance Name | POLYMYXIN B SULFATE |
|---|
| Strength | 500000 |
|---|
| Strength Unit | [USP'U]/1 |
|---|
| Pharmacy Classes | Polymyxin-class Antibacterial [EPC], Polymyxins [CS] |
|---|