Product NDC: | 55390-391 |
Proprietary Name: | gemcitabine |
Non Proprietary Name: | gemcitabine |
Active Ingredient(s): | 40 mg/mL & nbsp; gemcitabine |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 55390-391 |
Labeler Name: | Bedford Laboratories |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA091365 |
Marketing Category: | ANDA |
Start Marketing Date: | 20120319 |
Package NDC: | 55390-391-50 |
Package Description: | 1 VIAL, SINGLE-USE in 1 CARTON (55390-391-50) > 25 mL in 1 VIAL, SINGLE-USE |
NDC Code | 55390-391-50 |
Proprietary Name | gemcitabine |
Package Description | 1 VIAL, SINGLE-USE in 1 CARTON (55390-391-50) > 25 mL in 1 VIAL, SINGLE-USE |
Product NDC | 55390-391 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | gemcitabine |
Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20120319 |
Marketing Category Name | ANDA |
Labeler Name | Bedford Laboratories |
Substance Name | GEMCITABINE HYDROCHLORIDE |
Strength Number | 40 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] |