Product NDC: | 0781-3282 |
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: | 0781-3282 |
Labeler Name: | Sandoz Inc |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA020509 |
Marketing Category: | NDA |
Start Marketing Date: | 20100827 |
Package NDC: | 0781-3282-75 |
Package Description: | 5 mL in 1 VIAL (0781-3282-75) |
NDC Code | 0781-3282-75 |
Proprietary Name | Gemcitabine HCl |
Package Description | 5 mL in 1 VIAL (0781-3282-75) |
Product NDC | 0781-3282 |
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 | 20100827 |
Marketing Category Name | NDA |
Labeler Name | Sandoz Inc |
Substance Name | GEMCITABINE HYDROCHLORIDE |
Strength Number | 200 |
Strength Unit | mg/5mL |
Pharmaceutical Classes | Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] |