General MedicationsSUBLINGUALGeneric

SUBSYS

FENTANYL

Standard Dose

0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Max Dose

Refer to approved labeling

Primary Use

Review priority: N/A Marketing status: Discontinued

Summary

Approval overview SUBSYS is listed in Drugs@FDA under application 202788 (NDA).

Review priority: N/A Marketing status: Discontinued Active ingredient FENTANYL Form and strength SPRAY;SUBLINGUAL - 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor BTCP PHARMA Submission history Latest submission status date: 2022-12-08 00:00:00.

Structured Monograph

Clinical summary

Approval overview SUBSYS is listed in Drugs@FDA under application 202788 (NDA). Review priority: N/A Marketing status: Discontinued Active ingredient FENTANYL Form and strength SPRAY;SUBLINGUAL - 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor BTCP PHARMA Submission history Latest submission status date: 2022-12-08 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: N/A

Interaction Notes

No interaction notes stored yet.