Pred Phos - Brom
Approved
Approval ID
6e28fdfe-03f4-0c1f-e053-2a91aa0a4bd5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 8, 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 Phosphate - Bromfenac
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71384-552
Product Classification
G
Generic Name
Prednisolone Phosphate - Bromfenac
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJune 8, 2018
FDA Product Classification
INGREDIENTS (2)
PREDNISOLONE SODIUM PHOSPHATEActive
Quantity: 10 mg in 1 mL
Code: IV021NXA9J
Classification: ACTIR
BROMFENAC SODIUMActive
Quantity: 0.75 mg in 1 mL
Code: 8ECV571Y37
Classification: ACTIM