Product NDC: | 63323-196 |
Proprietary Name: | Fludarabine |
Non Proprietary Name: | FLUDARABINE PHOSPHATE |
Active Ingredient(s): | 25 mg/mL & nbsp; FLUDARABINE PHOSPHATE |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 63323-196 |
Labeler Name: | APP Pharmaceuticals, LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA078544 |
Marketing Category: | ANDA |
Start Marketing Date: | 20091211 |
Package NDC: | 63323-196-06 |
Package Description: | 1 VIAL in 1 BOX (63323-196-06) > 2 mL in 1 VIAL |
NDC Code | 63323-196-06 |
Proprietary Name | Fludarabine |
Package Description | 1 VIAL in 1 BOX (63323-196-06) > 2 mL in 1 VIAL |
Product NDC | 63323-196 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | FLUDARABINE PHOSPHATE |
Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20091211 |
Marketing Category Name | ANDA |
Labeler Name | APP Pharmaceuticals, LLC |
Substance Name | FLUDARABINE PHOSPHATE |
Strength Number | 25 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] |