General MedicationsOPHTHALMICStandard
LOTEPREDNOL ETABONATE
LOTEPREDNOL ETABONATE
Standard Dose
0.38%
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview LOTEPREDNOL ETABONATE is listed in Drugs@FDA under application 218087 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient LOTEPREDNOL ETABONATE Form and strength GEL;OPHTHALMIC - 0.38% Sponsor LUPIN LTD Submission history Latest submission status date: 2025-06-30 00:00:00.
Structured Monograph
Clinical summary
Approval overview LOTEPREDNOL ETABONATE is listed in Drugs@FDA under application 218087 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient LOTEPREDNOL ETABONATE Form and strength GEL;OPHTHALMIC - 0.38% Sponsor LUPIN LTD Submission history Latest submission status date: 2025-06-30 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.