General MedicationsSUBLINGUALGeneric

ABSTRAL

FENTANYL CITRATE

Standard Dose

EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: STANDARD Marketing status: Discontinued

Summary

Approval overview ABSTRAL is listed in Drugs@FDA under application 022510 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient FENTANYL CITRATE Form and strength TABLET;SUBLINGUAL - EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor SENTYNL THERAPS INC Submission history Latest submission status date: 2019-10-07 00:00:00.

Structured Monograph

Clinical summary

Approval overview ABSTRAL is listed in Drugs@FDA under application 022510 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient FENTANYL CITRATE Form and strength TABLET;SUBLINGUAL - EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor SENTYNL THERAPS INC Submission history Latest submission status date: 2019-10-07 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.