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General MedicationsINTRAVENOUSGeneric

CALDOLOR

IBUPROFEN

Standard Dose
400MG/4ML (100MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview CALDOLOR is listed in Drugs@FDA under application 022348 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient IBUPROFEN Form and strength SOLUTION;INTRAVENOUS - 400MG/4ML (100MG/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: Discontinued Active ingredient IBUPROFEN Form and strength SOLUTION;INTRAVENOUS - 400MG/4ML (100MG/ML) Sponsor CUMBERLAND PHARMS Submission history Latest submission status date: 2026-01-23 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.