Product NDC: | 25021-208 |
Proprietary Name: | Gemcitabine |
Non Proprietary Name: | gemcitabine hydrochloride |
Active Ingredient(s): | 200 mg/5mL & nbsp; gemcitabine hydrochloride |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 25021-208 |
Labeler Name: | Sagent Pharmaceuticals |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA079160 |
Marketing Category: | ANDA |
Start Marketing Date: | 20110725 |
Package NDC: | 25021-208-10 |
Package Description: | 1 VIAL in 1 CARTON (25021-208-10) > 5 mL in 1 VIAL |
NDC Code | 25021-208-10 |
Proprietary Name | Gemcitabine |
Package Description | 1 VIAL in 1 CARTON (25021-208-10) > 5 mL in 1 VIAL |
Product NDC | 25021-208 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | gemcitabine hydrochloride |
Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20110725 |
Marketing Category Name | ANDA |
Labeler Name | Sagent Pharmaceuticals |
Substance Name | GEMCITABINE HYDROCHLORIDE |
Strength Number | 200 |
Strength Unit | mg/5mL |
Pharmaceutical Classes | Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] |