Pred-Brom
Approved
Approval ID
63254869-67d5-0900-e053-2a91aa0af95c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2018
Manufacturers
FDA
Imprimis NJOF, LLC
DUNS: 080431967
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Prednisolone Acetate-Bromfenac
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71384-505
Product Classification
G
Generic Name
Prednisolone Acetate-Bromfenac
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 19, 2018
FDA Product Classification
INGREDIENTS (2)
PREDNISOLONE ACETATEActive
Quantity: 10 mg in 1 mL
Code: 8B2807733D
Classification: ACTIB
BROMFENAC SODIUMActive
Quantity: 0.75 mg in 1 mL
Code: 8ECV571Y37
Classification: ACTIM