gatifloxacin
These highlights do not include all the information needed to use gatifloxacin safely and effectively. See full prescribing information for gatifloxacin . G atifloxacin ophthalmic solution 0.5% for topical ophthalmic use Initial U.S. Approval: 1999
Approved
Approval ID
3dd6ac6b-877a-46c7-bbc8-c7119f341abe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 1, 2016
Manufacturers
FDA
Pacific Pharma, Inc.
DUNS: 877645267
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
gatifloxacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60758-615
Application NumberNDA022548
Product Classification
M
Marketing Category
C73605
G
Generic Name
gatifloxacin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 17, 2023
FDA Product Classification
INGREDIENTS (7)
gatifloxacinActive
Quantity: 5 mg in 1 mL
Code: L4618BD7KJ
Classification: ACTIB
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
benzalkonium chlorideInactive
Code: F5UM2KM3W7
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT