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

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