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General MedicationsNASALStandard

BUTORPHANOL TARTRATE

BUTORPHANOL TARTRATE

Standard Dose
1MG/SPRAY
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview BUTORPHANOL TARTRATE is listed in Drugs@FDA under application 075824 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient BUTORPHANOL TARTRATE Form and strength SPRAY, METERED;NASAL - 1MG/SPRAY Sponsor HIKMA Submission history Latest submission status date: 2025-12-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview BUTORPHANOL TARTRATE is listed in Drugs@FDA under application 075824 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient BUTORPHANOL TARTRATE Form and strength SPRAY, METERED;NASAL - 1MG/SPRAY Sponsor HIKMA Submission history Latest submission status date: 2025-12-22 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.