ZYMAXID
These highlights do not include all the information needed to use ZYMAXID safely and effectively. See full prescribing information for ZYMAXID.ZYMAXID (gatifloxacin ophthalmic solution) 0.5% Initial U.S. Approval: 1999
Approved
Approval ID
218fba79-c773-482d-90aa-7cf678694c36
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 6, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
gatifloxacin
PRODUCT DETAILS
NDC Product Code54868-6303
Application NumberNDA022548
Marketing CategoryC73594
Route of AdministrationOPHTHALMIC
Effective DateFebruary 6, 2012
Generic Namegatifloxacin
INGREDIENTS (7)
gatifloxacinActive
Quantity: 5 mg in 1 mL
Code: L4618BD7KJ
Classification: ACTIB
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
benzalkonium chlorideInactive
Code: F5UM2KM3W7
Classification: IACT