Product NDC: | 0069-3857 |
Proprietary Name: | Gemcitabine Hydrochloride |
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: | 0069-3857 |
Labeler Name: | Pfizer Laboratories Div Pfizer Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA200145 |
Marketing Category: | ANDA |
Start Marketing Date: | 20110725 |
Package NDC: | 0069-3857-10 |
Package Description: | 5 mL in 1 VIAL (0069-3857-10) |
NDC Code | 0069-3857-10 |
Proprietary Name | Gemcitabine Hydrochloride |
Package Description | 5 mL in 1 VIAL (0069-3857-10) |
Product NDC | 0069-3857 |
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 | Pfizer Laboratories Div Pfizer Inc. |
Substance Name | GEMCITABINE HYDROCHLORIDE |
Strength Number | 200 |
Strength Unit | mg/5mL |
Pharmaceutical Classes | Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] |