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General MedicationsORALStandard

DIAZEPAM

DIAZEPAM

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

Approval overview DIAZEPAM is listed in Drugs@FDA under application 204433 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DIAZEPAM Form and strength CONCENTRATE;ORAL - 5MG/ML Sponsor CHARTWELL MOLECULAR Submission history Latest submission status date: 2023-01-17 00:00:00.

Structured Monograph

Clinical summary

Approval overview DIAZEPAM is listed in Drugs@FDA under application 204433 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DIAZEPAM Form and strength CONCENTRATE;ORAL - 5MG/ML Sponsor CHARTWELL MOLECULAR Submission history Latest submission status date: 2023-01-17 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.