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 Drug Recalls 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… 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 ^ 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 | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com