General MedicationsORALStandard
SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE
Standard Dose
EQ 20MG BASE/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview SERTRALINE HYDROCHLORIDE is listed in Drugs@FDA under application 078861 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient SERTRALINE HYDROCHLORIDE Form and strength CONCENTRATE;ORAL - EQ 20MG BASE/ML Sponsor AUROBINDO PHARMA Submission history Latest submission status date: 2024-02-02 00:00:00.
Structured Monograph
Clinical summary
Approval overview SERTRALINE HYDROCHLORIDE is listed in Drugs@FDA under application 078861 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient SERTRALINE HYDROCHLORIDE Form and strength CONCENTRATE;ORAL - EQ 20MG BASE/ML Sponsor AUROBINDO PHARMA Submission history Latest submission status date: 2024-02-02 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.