General MedicationsINJECTIONStandard

DEXMEDETOMIDINE HYDROCHLORIDE

Standard Dose

EQ 200MCG BASE/50ML (EQ 4MCG 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 217308 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DEXMEDETOMIDINE HYDROCHLORIDE Form and strength INJECTABLE;INJECTION - EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) Sponsor MILLA PHARMS Submission history Latest submission status date: 2023-06-07 00:00:00.

Structured Monograph

Clinical summary

Approval overview DEXMEDETOMIDINE HYDROCHLORIDE is listed in Drugs@FDA under application 217308 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DEXMEDETOMIDINE HYDROCHLORIDE Form and strength INJECTABLE;INJECTION - EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) Sponsor MILLA PHARMS Submission history Latest submission status date: 2023-06-07 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.