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General MedicationsINTRAMUSCULAR, SUBCUTANEOUSStandard

AUVI-Q

EPINEPHRINE

Standard Dose
EQ 0.3MG/DELIVERY
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview AUVI-Q is listed in Drugs@FDA under application 201739 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient EPINEPHRINE Form and strength SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - EQ 0.3MG/DELIVERY Sponsor KALEO INC Submission history Latest submission status date: 2025-04-30 00:00:00.

Structured Monograph

Clinical summary

Approval overview AUVI-Q is listed in Drugs@FDA under application 201739 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient EPINEPHRINE Form and strength SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - EQ 0.3MG/DELIVERY Sponsor KALEO INC Submission history Latest submission status date: 2025-04-30 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.