General MedicationsOPHTHALMICStandard

BROMFENAC SODIUM

Standard Dose

EQ 0.07% ACID

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview BROMFENAC SODIUM is listed in Drugs@FDA under application 214340 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient BROMFENAC SODIUM Form and strength SOLUTION/DROPS;OPHTHALMIC - EQ 0.07% ACID Sponsor ALEMBIC Submission history Latest submission status date: 2024-07-08 00:00:00.

Structured Monograph

Clinical summary

Approval overview BROMFENAC SODIUM is listed in Drugs@FDA under application 214340 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient BROMFENAC SODIUM Form and strength SOLUTION/DROPS;OPHTHALMIC - EQ 0.07% ACID Sponsor ALEMBIC Submission history Latest submission status date: 2024-07-08 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.