MedPath

Pred-Gati-Brom

Approved
Approval ID

65d1a00a-54fb-5afd-e053-2991aa0a69a9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 22, 2018

Manufacturers
FDA

ImprimisRx NJ

DUNS: 931390178

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Prednisolone-Gatifloxacin-Bromfenac

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70261-504
Product Classification
G
Generic Name
Prednisolone-Gatifloxacin-Bromfenac
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateFebruary 22, 2018
FDA Product Classification

INGREDIENTS (3)

BROMFENACActive
Quantity: 0.75 mg in 1 mL
Code: 864P0921DW
Classification: ACTIB
PREDNISOLONE ACETATEActive
Quantity: 10 mg in 1 mL
Code: 8B2807733D
Classification: ACTIB
GATIFLOXACIN HEMIHYDRATEActive
Quantity: 5 mg in 1 mL
Code: AN201CY09J
Classification: ACTIB

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Pred-Gati-Brom - FDA Drug Approval Details