| 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 | SpecGx LLC | LTS Lohmann Therapy Systems Corp. | 20260430 | 58 |
| 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 | Hospira, Inc. | 20260407 | 17 |
| 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 | Aveva Drug Delivery Systems Inc. | DifGen Pharmaceuticals LLC | 20260407 | 2 |
| 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 | INGENUS PHARMACEUTICALS, LLC | DifGen Pharmaceuticals LLC | Aveva Drug Delivery Systems Inc. | 20260407 | 6 |
| 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 | Hikma Pharmaceuticals USA Inc. | 20260306 | 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 | ALVOGEN | Kindeva Drug Delivery L.P. | 20260302 | 27 |
| 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 | Hospira, Inc. | 20260225 | 34 |
| 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 | Teva Pharmaceuticals USA, Inc. | 20260131 | 16 |
| 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 | Civica, Inc. | Hikma Pharmaceuticals USA Inc. | 20251226 | 13 |
| 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 | Phlow Corp. | Hikma Pharmaceuticals USA Inc. | 20251223 | 10 |
| 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 | Hikma Pharmaceuticals USA Inc. | 20251219 | 3 |
| 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 | Mylan Pharmaceuticals Inc. | 20251215 | 27 |
| 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 | Fresenius Kabi USA, LLC | 20250924 | 6 |
| 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 | Fresenius Kabi USA, LLC | 20241231 | 10 |
| 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 | Akorn | 20220909 | 15 |
| 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 | Insys Therapeutics, Inc. | 20210504 | 21 |
| 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 | West Therapeutics Development, LLC | 20210428 | 23 |
| Lazanda (fentanyl citrate) Nasal Spray, 100 mcg, 300 mcg, 400 mcg | West Therapeutic Development LLC | Renaissance Lakewood LLC | 20210331 | 4 |
| FENTANYL | DirectRX | 20200120 | 3 |
| FENTANYL | DirectRX | 20200120 | 3 |
| eec9848f-56b0-428c-becd-4f9c7100faed | Mylan Technologies Inc. | 20190122 | 3 |
| Fentanyl Citrate 1 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Bag | Cantrell Drug Company | 20150112 | 6 |
| Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Bag | Cantrell Drug Company | 20150112 | 5 |
| Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 125 mL Bag | Cantrell Drug Company | 20150112 | 2 |
| 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 | Galena Biopharma, Inc. | Pharmaceutics International, Inc. | 20141130 | 2 |
| Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 250 mL Bag | Cantrell Drug Company | 20140813 | 3 |
| Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 250 mL Bag | Cantrell Drug Company | 20140813 | 8 |
| Fentanyl Citrate 5 mcg/mL in 0.9% Sodium Chloride 3 mL Syringe | Cantrell Drug Company | 20140813 | 4 |
| Fentanyl Citrate 3 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 200 mL Bag | Cantrell Drug Company | 20140812 | 5 |
| Fentanyl Citrate 20 mcg/mL in 0.9% Sodium Chloride 30 mL PCA Vial, Non-MedNet | Cantrell Drug Company | 20140806 | 1 |
| Fentanyl Citrate 50 mcg/mL in Sterile Water 2 mL Syringe | Cantrell Drug Company | 20140502 | 5 |
| Fentanyl Citrate 50 mcg/mL in Sterile Water 5 mL Syringe | Cantrell Drug Company | 20140502 | 5 |
| Fentanyl Citrate 50 mcg/mL in Sterile Water 20 mL Syringe | Cantrell Drug Company | 20140430 | 6 |
| Fentanyl Citrate 20 mcg/mL in 0.9% Sodium Chloride 100 mL Bag | Cantrell Drug Company | 20130515 | 3 |
| Fentanyl Citrate 20 mcg/mL in 0.9% Sodium Chloride 30 mL PCA Vial | Cantrell Drug Company | 20130405 | 1 |
| 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 | Archimedes Pharma US Inc. | 20120730 | 5 |
| 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 | ProStrakan, Inc. | Novartis Consumer Health, Inc. | 20120229 | 3 |
| Fentanyl Transdermal System C-II Revised: August 2008 Rx only | STAT Rx USA LLC | PSS World Medical Inc. | 20120130 | 4 |
| FENTANYL TRANSDERMAL SYSTEM CII | H.J. Harkins Company, Inc. | 20120119 | 3 |
| FENTANYL TRANSDERMAL SYSTEM CII | H.J. Harkins Company, Inc. | 20120119 | 3 |
| 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 | Rebel Distributors Corp. | 20111004 | 1 |
| 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 | Rebel Distributors Corp | 20110907 | 1 |
| 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 | H.J. Harkins Company, Inc. | Cephalon Inc. | 20110906 | 1 |
| FENTANYL TRANSDERMAL SYSTEM CII | Dispensing Solutions, Inc. | 20110901 | 1 |
| 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 | Physicians Total Care, Inc. | 20110317 | 2 |
| FENTANYL TRANSDERMAL SYSTEM CII Rx only | Dispensing Solutions Inc. | 20100303 | 1 |
| b7fe401c-7ddc-4391-9cff-3608da03e86b | Physicians Total Care, Inc. | 20091216 | 2 |