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General MedicationsSUBLINGUALGeneric

SUBSYS

FENTANYL

Standard Dose
0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Form and strength SPRAY;SUBLINGUAL - 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor BTCP PHARMA Submission history Latest submission status date: 2022-12-08 00:00:00.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Form and strength SPRAY;SUBLINGUAL - 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor BTCP PHARMA Submission history Latest submission status date: 2022-12-08 00:00:00.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.