| These highlights do not include all the information needed to use FENTANYL CITRATE INJECTION safely and effectively. See full prescribing information for FENTANYL CITRATE INJECTION. FENTANYL CITRATE Injection, for Intravenous or Intramuscular use, CII Initial U.S. Approval: 1968 | Product name | Hospira, Inc. | 2026-08-24 |
| These highlights do not include all the information needed to use FENTANYL TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for FENTANYL TRANSDERMAL SYSTEM. FENTANYL transdermal system, CII Initial U.S. Approval: 1968 | Product name | SpecGx LLC | LTS Lohmann Therapy Systems Corp. | 2026-04-30 |
| These highlights do not include all the information needed to use FENTANYL CITRATE INJECTION safely and effectively. See full prescribing information for FENTANYL CITRATE INJECTION. FENTANYL CITRATE Injection, for Intravenous or Intramuscular use, CII Initial U.S. Approval: 1968 | Product name | Hospira, Inc. | 2026-04-07 |
| These highlights do not include all the information needed to use FENTANYL TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for FENTANYL TRANSDERMAL SYSTEM. FENTANYL transdermal system, CII Initial U.S. Approval: 1968 | Product name | Aveva Drug Delivery Systems Inc. | DifGen Pharmaceuticals LLC | 2026-04-07 |
| These highlights do not include all the information needed to use FENTANYL TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for FENTANYL TRANSDERMAL SYSTEM. FENTANYL transdermal system, CII Initial U.S. Approval: 1968 | Product name | INGENUS PHARMACEUTICALS, LLC | DifGen Pharmaceuticals LLC | Aveva Drug Delivery Systems Inc. | 2026-04-07 |
| These highlights do not include all the information needed to use FENTANYL CITRATE INJECTION safely and effectively. See full prescribing information for FENTANYL CITRATE INJECTION. Fentanyl Citrate Injection, for intravenous or intramuscular use, CII Initial U.S. Approval: 1968 | Product name | Hikma Pharmaceuticals USA Inc. | 2026-03-06 |
| These highlights do not include all the information needed to use FENTANYL TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for FENTANYL TRANSDERMAL SYSTEM. FENTANYL transdermal system, CII Initial U.S. Approval: 1968 | Product name | ALVOGEN | Kindeva Drug Delivery L.P. | 2026-03-02 |
| These highlights do not include all the information needed to use FENTANYL CITRATE INJECTION safely and effectively. See full prescribing information for FENTANYL CITRATE INJECTION. FENTANYL CITRATE Injection, for Intravenous or Intramuscular use, CII Initial U.S. Approval: 1968 | Product name | Hospira, Inc. | 2026-02-25 |
| These highlights do not include all the information needed to use Oral Transmucosal Fentanyl Citrate (OTFC) safely and effectively. See full prescribing information for OTFC. Oral Transmucosal Fentanyl Citrate (OTFC) (fentanyl citrate) oral transmucosal lozenge, CII Initial U.S. Approval: 1968 | Product name | Teva Pharmaceuticals USA, Inc. | 2026-01-31 |
| These highlights do not include all the information needed to use FENTANYL CITRATE INJECTION safely and effectively. See full prescribing information for FENTANYL CITRATE INJECTION. Fentanyl Citrate Injection, for intravenous or intramuscular use, CII Initial U.S. Approval: 1968 | Product name | Civica, Inc. | Hikma Pharmaceuticals USA Inc. | 2026-01-21 |
| These highlights do not include all the information needed to use FENTANYL CITRATE INJECTION safely and effectively. See full prescribing information for FENTANYL CITRATE INJECTION. Fentanyl Citrate Injection, for intravenous or intramuscular use, CII Initial U.S. Approval: 1968 | Product name | Hikma Pharmaceuticals USA Inc. | 2026-01-21 |
| These highlights do not include all the information needed to use FENTANYL CITRATE INJECTION safely and effectively. See full prescribing information for FENTANYL CITRATE INJECTION. Fentanyl Citrate Injection, for intravenous or intramuscular use, CII Initial U.S. Approval: 1968 | Product name | Hikma Pharmaceuticals USA Inc. | 2026-01-21 |
| These highlights do not include all the information needed to use FENTANYL CITRATE INJECTION safely and effectively. See full prescribing information for FENTANYL CITRATE INJECTION. FENTANYL CITRATE Injection, for Intravenous or Intramuscular use, CII Initial U.S. Approval: 1968 | Product name | Hospira, Inc. | 2025-12-31 |
| These highlights do not include all the information needed to use FENTANYL CITRATE INJECTION safely and effectively. See full prescribing information for FENTANYL CITRATE INJECTION. Fentanyl Citrate Injection, for intravenous or intramuscular use, CII Initial U.S. Approval: 1968 | Product name | Civica, Inc. | Hikma Pharmaceuticals USA Inc. | 2025-12-26 |
| These highlights do not include all the information needed to use FENTANYL TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for FENTANYL TRANSDERMAL SYSTEM. FENTANYL transdermal system, CII Initial U.S. Approval: 1968 | Product name | SpecGx LLC | LTS Lohmann Therapy Systems Corp. | 2025-12-24 |
| These highlights do not include all the information needed to use FENTANYL CITRATE INJECTION safely and effectively. See full prescribing information for FENTANYL CITRATE INJECTION. Fentanyl Citrate Injection, for intravenous or intramuscular use, CII Initial U.S. Approval: 1968 | Product name | Phlow Corp. | Hikma Pharmaceuticals USA Inc. | 2025-12-23 |
| These highlights do not include all the information needed to use FENTANYL CITRATE INJECTION safely and effectively. See full prescribing information for FENTANYL CITRATE INJECTION. Fentanyl Citrate Injection, for intravenous or intramuscular use, CII Initial U.S. Approval: 1968 | Product name | Hikma Pharmaceuticals USA Inc. | 2025-12-19 |
| These highlights do not include all the information needed to use FENTANYL TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for FENTANYL TRANSDERMAL SYSTEM. FENTANYL transdermal system CII Initial U.S. Approval: 1968 | Product name | Mylan Pharmaceuticals Inc. | 2025-12-15 |
| These highlights do not include all the information needed to use FENTANYL CITRATE INJECTION safely and effectively. See full prescribing information for FENTANYL CITRATE INJECTION. Fentanyl Citrate Injection, for intravenous or intramuscular use, CII Initial U.S. Approval: 1968 | Product name | Hikma Pharmaceuticals USA Inc. | 2025-12-10 |
| These highlights do not include all the information needed to use FENTANYL TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for FENTANYL TRANSDERMAL SYSTEM. FENTANYL transdermal system, CII Initial U.S. Approval: 1968 | Product name | ALVOGEN | Kindeva Drug Delivery L.P. | 2025-12-04 |
| These highlights do not include all the information needed to use FENTANYL TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for FENTANYL TRANSDERMAL SYSTEM. FENTANYL transdermal system, CII Initial U.S. Approval: 1968 | Product name | INGENUS PHARMACEUTICALS, LLC | DifGen Pharmaceuticals LLC | Aveva Drug Delivery Systems Inc. | 2025-11-18 |
| These highlights do not include all the information needed to use FENTANYL TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for FENTANYL TRANSDERMAL SYSTEM. FENTANYL transdermal system CII Initial U.S. Approval: 1968 | Product name | Mylan Pharmaceuticals Inc. | 2025-10-28 |
| These highlights do not include all the information needed to use FENTANYL TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for FENTANYL TRANSDERMAL SYSTEM. FENTANYL transdermal system CII Initial U.S. Approval: 1968 | Product name | Mylan Pharmaceuticals Inc. | 2025-10-28 |
| These highlights do not include all the information needed to use FENTANYL CITRATE INJECTION safely and effectively. See full prescribing information for FENTANYL CITRATE INJECTION. FENTANYL CITRATE injection, for intravenous or intramuscular use, CII Initial U.S. Approval: 1968 | Product name | Fresenius Kabi USA, LLC | 2025-09-24 |
| These highlights do not include all the information needed to use FENTANYL TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for FENTANYL TRANSDERMAL SYSTEM. FENTANYL transdermal system CII Initial U.S. Approval: 1968 | Product name | Mylan Pharmaceuticals Inc. | 2025-08-07 |
| These highlights do not include all the information needed to use FENTANYL CITRATE INJECTION safely and effectively. See full prescribing information for FENTANYL CITRATE INJECTION. FENTANYL CITRATE injection, for intravenous or intramuscular use, CII Initial U.S. Approval: 1968 | Product name | Fresenius Kabi USA, LLC | 2024-12-31 |
| Instanyl Fentanyl Nasal Spray | Product name | Renaissance Lakewood LLC | 2024-11-27 |
| Risk Evaluation and Mitigation Strategy (REMS) Document Opioid Analgesic Shared System REMS | Product name | Syneos Health | 2024-10-31 |
| Risk Evaluation and Mitigation Strategy (REMS) Document Transmucosal Immediate Release Fentanyl (TIRF) Shared System REMS Program | Product name | Examoto, LLC | 2024-08-28 |
| These highlights do not include all the information needed to use FENTANYL CITRATE INJECTION safely and effectively. See full prescribing information for FENTANYL CITRATE INJECTION. Fentanyl Citrate Injection, for intravenous or intramuscular use, CII Initial U.S. Approval: 1968 | Product name | Akorn | 2022-09-09 |
| These highlights do not include all the information needed to use SUBSYS safely and effectively. See full prescribing information for SUBSYS. SUBSYS®(fentanyl sublingual spray), CII Initial U.S. Approval: 1968 | Product name | Insys Therapeutics, Inc. | 2021-05-04 |
| These highlights do not include all the information needed to use SUBSYS safely and effectively. See full prescribing information for SUBSYS. SUBSYS®(fentanyl sublingual spray), CII Initial U.S. Approval: 1968 | Product name | West Therapeutics Development, LLC | 2021-04-28 |
| Lazanda (fentanyl citrate) Nasal Spray, 100 mcg, 300 mcg, 400 mcg | Product name | West Therapeutic Development LLC | Renaissance Lakewood LLC | 2021-03-31 |
| FENTANYL | Product name | DirectRX | 2020-01-20 |
| FENTANYL | Product name | DirectRX | 2020-01-20 |
| Mylan Technologies Inc. human prescription drug label | Product name | Mylan Technologies Inc. | 2019-01-22 |
| Fentanyl Citrate 1 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Bag | Product name | Cantrell Drug Company | 2015-01-12 |
| Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Bag | Product name | Cantrell Drug Company | 2015-01-12 |
| Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 125 mL Bag | Product name | Cantrell Drug Company | 2015-01-12 |
| These highlights do not include all the information needed to use ABSTRAL safely and effectively. See full prescribing information for ABSTRAL. ABSTRAL ® (fentanyl) sublingual tablets CII Initial U.S. Approval: 1968 | Product name | Galena Biopharma, Inc. | Pharmaceutics International, Inc. | 2014-11-30 |
| Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 250 mL Bag | Product name | Cantrell Drug Company | 2014-08-13 |
| Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 250 mL Bag | Product name | Cantrell Drug Company | 2014-08-13 |
| Fentanyl Citrate 5 mcg/mL in 0.9% Sodium Chloride 3 mL Syringe | Product name | Cantrell Drug Company | 2014-08-13 |
| Fentanyl Citrate 3 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 200 mL Bag | Product name | Cantrell Drug Company | 2014-08-12 |
| Fentanyl Citrate 20 mcg/mL in 0.9% Sodium Chloride 30 mL PCA Vial, Non-MedNet | Product name | Cantrell Drug Company | 2014-08-06 |
| Fentanyl Citrate 50 mcg/mL in Sterile Water 2 mL Syringe | Product name | Cantrell Drug Company | 2014-05-02 |
| Fentanyl Citrate 50 mcg/mL in Sterile Water 5 mL Syringe | Product name | Cantrell Drug Company | 2014-05-02 |
| Fentanyl Citrate 50 mcg/mL in Sterile Water 20 mL Syringe | Product name | Cantrell Drug Company | 2014-04-30 |
| Fentanyl Citrate 20 mcg/mL in 0.9% Sodium Chloride 100 mL Bag | Product name | Cantrell Drug Company | 2013-05-15 |
| Fentanyl Citrate 20 mcg/mL in 0.9% Sodium Chloride 30 mL PCA Vial | Product name | Cantrell Drug Company | 2013-04-05 |
| These highlights do not include all the information needed to use LAZANDA safely and effectively. See full prescribing information for LAZANDA Lazanda ® (Fentanyl) Nasal Spray CII Initial U.S. Approval: 1968 | Product name | Archimedes Pharma US Inc. | 2012-07-30 |
| These highlights do not include all the information needed to use ABSTRAL safely and effectively. See full prescribing information for ABSTRAL. ABSTRAL ® (fentanyl) sublingual tablets CII Initial U.S. Approval: 1968 | Product name | ProStrakan, Inc. | Novartis Consumer Health, Inc. | 2012-02-29 |
| Fentanyl Transdermal System C-II Revised: August 2008 Rx only | Product name | STAT Rx USA LLC | PSS World Medical Inc. | 2012-01-30 |
| FENTANYL TRANSDERMAL SYSTEM CII | Product name | H.J. Harkins Company, Inc. | 2012-01-19 |
| FENTANYL TRANSDERMAL SYSTEM CII | Product name | H.J. Harkins Company, Inc. | 2012-01-19 |
| FENTANYL TRANSDERMAL SYSTEM 25 mcg/hr, 50 mcg/hr, 75 mcg/hr, 100 mcg/hr CII Full Prescribing Information Rx only FOR USE IN OPIOID-TOLERANT PATIENTS ONLY | Product name | Rebel Distributors Corp. | 2011-10-04 |
| FENTANYL TRANSDERMAL SYSTEM 25 mcg/hr, 50 mcg/hr, 75 mcg/hr, 100 mcg/hr CII Full Prescribing Information Rx only FOR USE IN OPIOID-TOLERANT PATIENTS ONLY | Product name | Rebel Distributors Corp | 2011-09-07 |
| These highlights do not include all the information needed to use Oral Transmucosal Fentanyl Citrate (OTFC) safely and effectively. See full prescribing information for OTFC. Oral Transmucosal Fentanyl Citrate (OTFC) (fentanyl citrate) oral transmucosal lozenge, CII Initial U.S. Approval: 1968 | Product name | H.J. Harkins Company, Inc. | Cephalon Inc. | 2011-09-06 |
| FENTANYL TRANSDERMAL SYSTEM CII | Product name | Dispensing Solutions, Inc. | 2011-09-01 |
| These highlights do not include all the information needed to use Oral Transmucosal Fentanyl Citrate (OTFC) safely and effectively. See full prescribing information for OTFC. Oral Transmucosal Fentanyl Citrate (OTFC) (fentanyl citrate) oral transmucosal lozenge, CII Initial U.S. Approval: 1968 | Product name | Physicians Total Care, Inc. | 2011-03-17 |
| FENTANYL TRANSDERMAL SYSTEM CII Rx only | Product name | Dispensing Solutions Inc. | 2010-03-03 |
| Physicians Total Care, Inc. human prescription drug label | Product name | Physicians Total Care, Inc. | 2009-12-16 |
| SUBLIMAZE ® Injection CII | Product name | Taylor Pharmaceuticals | 2008-04-21 |