Product NDC: | 16729-117 |
Proprietary Name: | Gemcitabine Hydrochloride |
Non Proprietary Name: | Gemcitabine Hydrochloride |
Active Ingredient(s): | 1 g/25mL & nbsp; Gemcitabine Hydrochloride |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 16729-117 |
Labeler Name: | Accord Healthcare, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA091594 |
Marketing Category: | ANDA |
Start Marketing Date: | 20110725 |
Package NDC: | 16729-117-11 |
Package Description: | 1 VIAL in 1 CARTON (16729-117-11) > 25 mL in 1 VIAL |
NDC Code | 16729-117-11 |
Proprietary Name | Gemcitabine Hydrochloride |
Package Description | 1 VIAL in 1 CARTON (16729-117-11) > 25 mL in 1 VIAL |
Product NDC | 16729-117 |
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 | Accord Healthcare, Inc. |
Substance Name | GEMCITABINE HYDROCHLORIDE |
Strength Number | 1 |
Strength Unit | g/25mL |
Pharmaceutical Classes | Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] |