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General MedicationsINTRAVENOUSStandard

DALBAVANCIN HYDROCHLORIDE

DALBAVANCIN HYDROCHLORIDE

Standard Dose
EQ 500MG BASE/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview DALBAVANCIN HYDROCHLORIDE is listed in Drugs@FDA under application 219465 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DALBAVANCIN HYDROCHLORIDE Form and strength POWDER;INTRAVENOUS - EQ 500MG BASE/VIAL Sponsor TEVA PHARMS INC Submission history Latest submission status date: 2025-10-23 00:00:00.

Structured Monograph

Clinical summary

Approval overview DALBAVANCIN HYDROCHLORIDE is listed in Drugs@FDA under application 219465 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DALBAVANCIN HYDROCHLORIDE Form and strength POWDER;INTRAVENOUS - EQ 500MG BASE/VIAL Sponsor TEVA PHARMS INC Submission history Latest submission status date: 2025-10-23 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.