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% for topical ophthalmic use Initial U.S. Approval: 1999
Approved
Approval ID
1160b16c-929a-4e85-9c0b-1d8c96a7678b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 1, 2016
Manufacturers
FDA
Allergan, Inc.
DUNS: 144796497
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 Code0023-3615
Application NumberNDA022548
Product Classification
M
Marketing Category
C73594
G
Generic Name
gatifloxacin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateNovember 16, 2022
FDA Product Classification
INGREDIENTS (7)
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
GATIFLOXACINActive
Quantity: 5 mg in 1 mL
Code: L4618BD7KJ
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT