Pred-Gati
Approved
Approval ID
65346afa-45cf-9f3b-e053-2991aa0ac8b1
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
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70261-502
Product Classification
G
Generic Name
Prednisolone-Gatifloxacin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateFebruary 22, 2018
FDA Product Classification
INGREDIENTS (3)
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Quantity: 1.9 mg in 1 mL
Code: 70WT22SF4B
Classification: IACT
PREDNISOLONE ACETATEActive
Quantity: 10 mg in 1 mL
Code: 8B2807733D
Classification: ACTIB
GATIFLOXACIN HEMIHYDRATEActive
Quantity: 5 mg in 1 mL
Code: AN201CY09J
Classification: ACTIB