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General MedicationsORALStandard

LIBRAX

CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE

Standard Dose
5MG;2.5MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview LIBRAX is listed in Drugs@FDA under application 012750 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE Form and strength CAPSULE;ORAL - 5MG;2.5MG Sponsor BAUSCH Submission history Latest submission status date: 2023-01-13 00:00:00.

Structured Monograph

Clinical summary

Approval overview LIBRAX is listed in Drugs@FDA under application 012750 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE Form and strength CAPSULE;ORAL - 5MG;2.5MG Sponsor BAUSCH Submission history Latest submission status date: 2023-01-13 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.