Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Safety Information For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

FDA Approval Activities for this Drug… Fludara (fludarabine) Injection, Berlex NDA 20-038/S28 8/1/03 8/15/03 8/15/03 Fludara (fludarabine phosphate) Berlex NDA 20-038/s19 12/3/01 4/21/03 Fludarabine Phosphate Injection USP, Sicor ANDA 76-349 FLUDARABINE PHOSPHATE Injection 50MG/VIAL FLUDARA BERLEX 076349 FLUDARABINE PHOSPHATE Injection 50MG/VIAL FLUDARABINE PHOSPHATE Gensia Sicor Fludarabine Phosphate Injection USP, Sicor Pharmaceuticals | Fludarabine Phosphate Injection, Mayne Pharma, Approval | Fludarabine Phosphate Injection, Ebewe Pharma, Approval | Fludarabine Phosphate Injection, Abraxis Pharma, Approval | Fludara (fludarabine phosphate) Injection, Bayer HealthCare, Labeling Revision | Fludarabine Phosphate (fludarabine phosphate) Tablets, Antisoma, Approval | Fludara (fludarabine phosphate) Injection, Bayer HealthCare Pharmaceuticals, Inc., Labeling Revision | Fludarabine Phosphate Injection, Actavis Totowa, LLC, Approval | Oforta (fludarabine phosphate) Tablets, Sanofi-Aventis U.S., LLC, Labeling Revision | Fludara (fludarabine phosphate) Injection, Genzyme Corporation, Labeling Revision | Fludarabine Phosphate Injection, Bioniche Pharma USA LLC, Approval | Fludarabine Phosphate Injection, Sandoz, Inc., Labeling Revision | Fludarabine Phosphate, fludarabine phosphate, Injectable; Injection, Onco Therapies Ltd, Approval ^ FDA's latest approval appears at the bottom of this list. ^                                                                       A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2012 Betterchem.com