General MedicationsORALStandard
ZALEPLON
ZALEPLON
Standard Dose
10MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview ZALEPLON is listed in Drugs@FDA under application 090374 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient ZALEPLON Form and strength CAPSULE;ORAL - 10MG Sponsor ORBION PHARMS Submission history Latest submission status date: 2019-10-21 00:00:00.
Structured Monograph
Clinical summary
Approval overview ZALEPLON is listed in Drugs@FDA under application 090374 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ZALEPLON Form and strength CAPSULE;ORAL - 10MG Sponsor ORBION PHARMS Submission history Latest submission status date: 2019-10-21 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.