| NDC Code | 71288-113-10 |
|---|
| Package Description | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-113-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
|---|
| Product NDC | 71288-113 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Gemcitabine |
|---|
| Non-Proprietary Name | Gemcitabine Hydrochloride |
|---|
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
|---|
| Usage | INTRAVENOUS |
|---|
| Start Marketing Date | 20181101 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA091365 |
|---|
| Manufacturer | Meitheal Pharmaceuticals Inc. |
|---|
| Substance Name | GEMCITABINE HYDROCHLORIDE |
|---|
| Strength | 200 |
|---|
| Strength Unit | mg/1 |
|---|
| Pharmacy Classes | Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC] |
|---|