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FDA Approval Activities for this Drug…
Duragesic (fentanyl transdermal system) Alza NDA 19-813/S-023 and S-030 Fentanyl Citrate Injection USP, 0.05 mg (base)/mL Marsam ANDA 74-917 Sublimaze (Fentanyl Citrate) Injection, Akron, NDA 16-619/S32 Sublimaze (Fentanyl Citrate) Injection, Akron, DROPERIDOL; FENTANYL CITRATE Injection 2.5MG/ML;EQ 0.05MG BASE/ML FENTANYL CITRATE AND DROPERIDOL Abbott | 019813 FENTANYL Film, Extended Release; Transdermal 0.6MG/24HR DURAGESIC ALZA | 019813 FENTANYL Film, Extended Release; Transdermal 1.2MG/24HR DURAGESIC ALZA | 019813 FENTANYL Film, Extended Release; Transdermal 1.8MG/24HR DURAGESIC ALZA | 019813 FENTANYL Film, Extended Release; Transdermal 2.4MG/24HR DURAGESIC ALZA | 019115 FENTANYL CITRATE Injection 0.05MG BASE/ML FENTANYL CITRATE Abbott | 072786 FENTANYL CITRATE Injection 0.05MG BASE/ML FENTANYL CITRATE PRESERVATIVE FREE Abbott | 016619 FENTANYL CITRATE Injection 0.05MG BASE/ML SUBLIMAZE PRESERVATIVE FREE Akorn MFG | 019101 FENTANYL CITRATE Injection 0.05MG BASE/ML FENTANYL CITRATE PRESERVATIVE FREE Baxter | 020747 FENTANYL CITRATE Troche/Lozenge; 0.2MG BASE ACTIQ ANESTA | 020747 FENTANYL CITRATE Troche/Lozenge; 0.4MG BASE ACTIQ ANESTA | 020747 FENTANYL CITRATE Troche/Lozenge; 0.6MG BASE ACTIQ ANESTA | 020747 FENTANYL CITRATE Troche/Lozenge; 0.8MG BASE ACTIQ ANESTA | 020747 FENTANYL CITRATE Troche/Lozenge; 1.2MG BASE ACTIQ ANESTA | 020747 FENTANYL CITRATE Troche/Lozenge; 1.6MG BASE ACTIQ ANESTA | Fentanyl Transdermal System, Mylan Technologies Fentanyl Transdermal System, Mylan | Actiq (oral transmucosal fentanyl citrate), Cephalon, Labeling Revision | Actiq (oral transmucosal fentanyl citrate), Cephalon, Labeling Revision | Fentanyl Transdermal System, Mylan Technologies, Approval | Duragesic (Fentanyl Transdermal System), Alza Corp, New Dosage Regimen | Actiq (oral transmucosal fentanyl citrate), Cephalon, Formulation Revision | Fentanyl Transdermal System, Lavipharm Labs, Approval | Actiq (oral transmucosal fentanyl citrate), Cephalon, Inc., Labeling Revision | FENTORA (fentanyl buccal tablet), Cephalon, Inc., Approval | Fentanyl Transdermal System, Mylan Technologies, New Strength | Actiq (oral transmucosal fentanyl citrate) Lozenge, Cephalon Inc., Patient Population Altered | FENTORA (fentanyl buccal) Tablet, Cephalon Inc., Control Supplement | FENTORA (fentanyl buccal) Tablet, Cephalon Inc., Labeling Revision | Fentanyl Transdermal System, Watson Labs, Approval | Fentanyl Transdermal System, Actavis, Approval | Fentanyl Transdermal System, Watson Labs, Approval | Fentanyl Transdermal System, Actavis, Control Supplement | Fentanyl Transdermal System, Lavipharm Labs, Control Supplement | Duragesic (fentanyl) Transdermal System, Alza Corp., Labeling Revision | FENTORA (fentanyl buccal) Tablet, Cephalon Inc., Labeling Revision | Onsolis (fentanyl) Buccal Soluble Film, BioDelivery Sciences International, Inc., Approval | Fentanyl Transdermal System, Hisamitsu Pharmaceutical Co., Inc., Approval | Fentanyl Citrate Oral Lozenge, Mallinckrodt Inc., Approval | Fentanyl Citrate Oral Lozenge, Barr Laboratories, Inc., Approval | Actiq (fentanyl citrate) Lozenges, Cephalon, Labeling Revision | Fentora (fentanyl citrate) Tablet, Cephalon, Inc., Labeling Revision | Fentanyl Tablets, Watson Laboratories, Inc., Tentative Approval | Onsolis (fentanyl citrate) Oral Soluble Film, Meda Pharmaceuticals, Inc., Labeling Revision | Fentora (fentanyl citrate) Tablets, Cephalon, Inc., Labeling Revision | Fentanyl Transdermal System, Mallinckrodt, Inc., Approval | Lazanda (fentanyl) Nasal Spray, Archimedes Development, Ltd., Approval | Actiq (fentanyl citrate) Oral Lozenge, Cephalon, Inc., Labeling Revision | Fentora (fentanyl citrate) Buccal Tablet, Cephalon, Inc., Labeling Revision | Abstral, fentanyl citrate, Tablet; Sublingual, Prostrakan Inc, Approval | Actiq, fentanyl citrate, Troche/Lozenge; Transmucosal, Cephalon, Approval | Fentora, fentanyl citrate, Tablet; Buccal, Cephalon, Approval | Lazanda, fentanyl citrate, Spray, Metered; Nasal, Archimedes, Approval | Onsolis, fentanyl citrate, Film; Buccal, Meda Pharms, Approval
  
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