Product NDC: | 57884-4001 |
Proprietary Name: | Gemcitabine HCl |
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: | 57884-4001 |
Labeler Name: | Jiangsu Hengrui Pharmaceutical Co., Ltd. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA202485 |
Marketing Category: | ANDA |
Start Marketing Date: | 20130508 |
Package NDC: | 57884-4001-1 |
Package Description: | 1 VIAL in 1 CARTON (57884-4001-1) > 5 mL in 1 VIAL |
NDC Code | 57884-4001-1 |
Proprietary Name | Gemcitabine HCl |
Package Description | 1 VIAL in 1 CARTON (57884-4001-1) > 5 mL in 1 VIAL |
Product NDC | 57884-4001 |
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 | 20130508 |
Marketing Category Name | ANDA |
Labeler Name | Jiangsu Hengrui Pharmaceutical Co., Ltd. |
Substance Name | GEMCITABINE HYDROCHLORIDE |
Strength Number | 200 |
Strength Unit | mg/5mL |
Pharmaceutical Classes | Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] |