General MedicationsOPHTHALMICStandard
BEPOTASTINE BESILATE
BEPOTASTINE BESILATE
Standard Dose
1.5%
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview BEPOTASTINE BESILATE is listed in Drugs@FDA under application 217770 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient BEPOTASTINE BESILATE Form and strength SOLUTION/DROPS;OPHTHALMIC - 1.5% Sponsor SOMERSET THERAPS LLC Submission history Latest submission status date: 2024-08-14 00:00:00.
Structured Monograph
Clinical summary
Approval overview BEPOTASTINE BESILATE is listed in Drugs@FDA under application 217770 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient BEPOTASTINE BESILATE Form and strength SOLUTION/DROPS;OPHTHALMIC - 1.5% Sponsor SOMERSET THERAPS LLC Submission history Latest submission status date: 2024-08-14 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.