Besivance
These highlights do not include all the information needed to use Besivance safely and effectively. See full prescribing information for Besivance. Besivance (besifloxacin ophthalmic suspension) 0.6%Sterile topical ophthalmic dropsInitial U.S. Approval: 2009
Approved
Approval ID
c326263e-4b55-41b6-b862-c970668669ec
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 1, 2009
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.
Besifloxacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6282
Application NumberNDA022308
Product Classification
M
Marketing Category
C73594
G
Generic Name
Besifloxacin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJuly 22, 2011
FDA Product Classification
INGREDIENTS (9)
BESIFLOXACINActive
Quantity: 6 mg in 1 mL
Code: BFE2NBZ7NX
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
POLYCARBOPHILInactive
Code: W25LM17A4W
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT