General MedicationsORALStandard
ESZOPICLONE
ESZOPICLONE
Standard Dose
3MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview ESZOPICLONE is listed in Drugs@FDA under application 208451 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient ESZOPICLONE Form and strength TABLET;ORAL - 3MG Sponsor AUROBINDO PHARMA Submission history Latest submission status date: 2019-11-04 00:00:00.
Structured Monograph
Clinical summary
Approval overview ESZOPICLONE is listed in Drugs@FDA under application 208451 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ESZOPICLONE Form and strength TABLET;ORAL - 3MG Sponsor AUROBINDO PHARMA Submission history Latest submission status date: 2019-11-04 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.