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FDA Approval

Pred-Brom

CompanyImprimis NJOF, LLC (DUNS: 080431967)

Effective Date

January 19, 2018

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Prednisolone acetate(10 mg in 1 mL)

Bromfenac(0.75 mg in 1 mL)

Products (1)

Pred-Brom

NDC Product Code

71384-505

Route of Administration

OPHTHALMIC

Effective Date

January 19, 2018

Ingredients

Prednisolone acetateActive

Code: 8B2807733DClass: ACTIBQuantity: 10 mg in 1 mL

BromfenacActive

Code: 8ECV571Y37Class: ACTIMQuantity: 0.75 mg in 1 mL

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