General MedicationsOPHTHALMICStandard

LOTEPREDNOL ETABONATE AND TOBRAMYCIN

LOTEPREDNOL ETABONATE; TOBRAMYCIN

Standard Dose

0.5%;0.3%

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview LOTEPREDNOL ETABONATE AND TOBRAMYCIN is listed in Drugs@FDA under application 217597 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient LOTEPREDNOL ETABONATE; TOBRAMYCIN Form and strength SUSPENSION/DROPS;OPHTHALMIC - 0.5%;0.3% Sponsor ALEMBIC Submission history Latest submission status date: 2025-12-10 00:00:00.

Structured Monograph

Clinical summary

Approval overview LOTEPREDNOL ETABONATE AND TOBRAMYCIN is listed in Drugs@FDA under application 217597 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient LOTEPREDNOL ETABONATE; TOBRAMYCIN Form and strength SUSPENSION/DROPS;OPHTHALMIC - 0.5%;0.3% Sponsor ALEMBIC Submission history Latest submission status date: 2025-12-10 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.