General MedicationsINTRAVENOUSStandard
CALDOLOR
IBUPROFEN
Standard Dose
800MG/200ML (4MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview CALDOLOR is listed in Drugs@FDA under application 022348 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient IBUPROFEN Form and strength SOLUTION;INTRAVENOUS - 800MG/200ML (4MG/ML) Sponsor CUMBERLAND PHARMS Submission history Latest submission status date: 2026-01-23 00:00:00.
Structured Monograph
Clinical summary
Approval overview CALDOLOR is listed in Drugs@FDA under application 022348 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient IBUPROFEN Form and strength SOLUTION;INTRAVENOUS - 800MG/200ML (4MG/ML) Sponsor CUMBERLAND PHARMS Submission history Latest submission status date: 2026-01-23 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.