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General MedicationsINJECTIONStandard

DEXMEDETOMIDINE HYDROCHLORIDE

DEXMEDETOMIDINE HYDROCHLORIDE

Standard Dose
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview DEXMEDETOMIDINE HYDROCHLORIDE is listed in Drugs@FDA under application 218675 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DEXMEDETOMIDINE HYDROCHLORIDE Form and strength INJECTABLE;INJECTION - EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Sponsor KNACK Submission history Latest submission status date: 2026-03-09 00:00:00.

Structured Monograph

Clinical summary

Approval overview DEXMEDETOMIDINE HYDROCHLORIDE is listed in Drugs@FDA under application 218675 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DEXMEDETOMIDINE HYDROCHLORIDE Form and strength INJECTABLE;INJECTION - EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) Sponsor KNACK Submission history Latest submission status date: 2026-03-09 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.