Product NDC: | 0024-5820 |
Proprietary Name: | Oforta |
Non Proprietary Name: | fludarabine phosphate |
Active Ingredient(s): | 10 mg/1 & nbsp; fludarabine phosphate |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, FILM COATED |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0024-5820 |
Labeler Name: | sanofi-aventis U.S. LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022273 |
Marketing Category: | NDA |
Start Marketing Date: | 20091231 |
Package NDC: | 0024-5820-20 |
Package Description: | 4 BLISTER PACK in 1 BOTTLE (0024-5820-20) > 5 TABLET, FILM COATED in 1 BLISTER PACK (0024-5820-05) |
NDC Code | 0024-5820-20 |
Proprietary Name | Oforta |
Package Description | 4 BLISTER PACK in 1 BOTTLE (0024-5820-20) > 5 TABLET, FILM COATED in 1 BLISTER PACK (0024-5820-05) |
Product NDC | 0024-5820 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | fludarabine phosphate |
Dosage Form Name | TABLET, FILM COATED |
Route Name | ORAL |
Start Marketing Date | 20091231 |
Marketing Category Name | NDA |
Labeler Name | sanofi-aventis U.S. LLC |
Substance Name | FLUDARABINE PHOSPHATE |
Strength Number | 10 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] |