General MedicationsORALStandard
LANSOPRAZOLE
LANSOPRAZOLE
Standard Dose
15MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview LANSOPRAZOLE is listed in Drugs@FDA under application 210465 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient LANSOPRAZOLE Form and strength TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL - 15MG Sponsor DR REDDYS Submission history Latest submission status date: 2023-09-19 00:00:00.
Structured Monograph
Clinical summary
Approval overview LANSOPRAZOLE is listed in Drugs@FDA under application 210465 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient LANSOPRAZOLE Form and strength TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL - 15MG Sponsor DR REDDYS Submission history Latest submission status date: 2023-09-19 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.