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General MedicationsNASALGeneric

LAZANDA

FENTANYL CITRATE

Standard Dose
EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N/A Marketing status: Discontinued
Summary

Approval overview LAZANDA is listed in Drugs@FDA under application 022569 (NDA).

Review priority: N/A Marketing status: Discontinued Active ingredient FENTANYL CITRATE Form and strength SPRAY, METERED;NASAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor BTCP PHARMA Submission history Latest submission status date: 2022-12-08 00:00:00.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 LAZANDA is listed in Drugs@FDA under application 022569 (NDA). Review priority: N/A Marketing status: Discontinued Active ingredient FENTANYL CITRATE Form and strength SPRAY, METERED;NASAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor BTCP PHARMA Submission history Latest submission status date: 2022-12-08 00:00:00.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.