Transmucosal Immediate Release Fentanyl (TIRF)
Risk Evaluation and Mitigation Strategy

Prescriber Patient Pharmacies Distributors TIRF Products  
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Products covered under the TIRF REMS Access Program

Brand Name Products

Trade Name Generic Name Company Contact Links
ABSTRAL®
Oral Transmucosal Fentanyl sublingual tablets
Sentynl Therapeutics Inc.
1-888-227-8725
ACTIQ®
Oral Transmucosal Fentanyl citrate oral transmucosal lozenge
Cephalon, Inc.
1-800-896-5855
FENTORA®
Oral Transmucosal Fentanyl buccal tablet
Cephalon, Inc.
1-800-896-5855
LAZANDA®
Oral Transmucosal Fentanyl nasal spray
Depomed, Inc.
1-866-458-6389
ONSOLIS®
Oral Transmucosal Fentanyl buccal soluble film
BioDelivery Sciences International, Inc.
1-855-365-6095
U.S. Prescribing Information and Medication Guide Not currently available
SUBSYS®
Oral Transmucosal Fentanyl sublingual spray
Insys Therapeutics Inc.
1-877-978-2797

Generic Products

Trade Name Generic Name Company Contact Links
Fentanyl Citrate
Oral Transmucosal Fentanyl Citrate Lozenge
Anesta Corp
1-800-896-5855
Fentanyl Citrate
Oral Transmucosal Fentanyl Citrate Lozenge
Mallinckrodt, Inc
1-800-778-7898
Fentanyl Citrate
Oral Transmucosal Fentanyl Citrate Lozenge
Par Pharmaceuticals
1-800-828-9393
The TRIG attests that the table above will only include products listed in the link titled 'List of approved application number and sponsors' on the FDA Approved REMS website.

For assistance, please call the TIRF REMS Access program at 1-866-822-1483.