Bepotastine Besilate
These highlights do not include all the information needed to use BEPOTASTINE BESILATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for BEPOTASTINE BESILATE OPHTHALMIC SOLUTION. BEPOTASTINE BESILATE ophthalmic solution, for topical application in the eyeInitial U.S. Approval: 2009
Approved
Approval ID
75178670-aa57-45f9-94d5-efcf8305e683
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 20, 2018
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bepotastine Besilate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-7055
Application NumberANDA206220
Product Classification
M
Marketing Category
C73584
G
Generic Name
Bepotastine Besilate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMarch 20, 2018
FDA Product Classification
INGREDIENTS (6)
BEPOTASTINE BESILATEActive
Quantity: 15 mg in 1 mL
Code: 6W18MO1QR3
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEInactive
Code: 5QWK665956
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT