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General MedicationsINTRAVENOUSStandard

COMBOGESIC IV

ACETAMINOPHEN; IBUPROFEN SODIUM

Standard Dose
1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview COMBOGESIC IV is listed in Drugs@FDA under application 215320 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ACETAMINOPHEN; IBUPROFEN SODIUM Form and strength SOLUTION;INTRAVENOUS - 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) Sponsor HIKMA Submission history Latest submission status date: 2024-11-21 00:00:00.

Structured Monograph

Clinical summary

Approval overview COMBOGESIC IV is listed in Drugs@FDA under application 215320 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ACETAMINOPHEN; IBUPROFEN SODIUM Form and strength SOLUTION;INTRAVENOUS - 1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) Sponsor HIKMA Submission history Latest submission status date: 2024-11-21 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.
COMBOGESIC IV (ACETAMINOPHEN; IBUPROFEN SODIUM) | Drug Monograph | MedicHelpline