BEPREVE
These highlights do not include all the information needed to use BEPREVE™ (bepotastine besilate ophthalmic solution) 1.5% safely and effectively. See full prescribing information for BEPREVE™.BEPREVE™ (bepotastine besilate ophthalmic solution) 1.5%Initial U.S. Approval: 2009
Approved
Approval ID
7c77517f-24c7-4778-94a7-873d11c3c657
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 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.
bepotastine besilate
PRODUCT DETAILS
NDC Product Code54868-6299
Application NumberNDA022288
Marketing CategoryC73594
Route of AdministrationOPHTHALMIC
Effective DateOctober 3, 2011
Generic Namebepotastine besilate
INGREDIENTS (6)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEInactive
Code: 5QWK665956
Classification: IACT
BEPOTASTINEActive
Quantity: 15 mg in 1 mL
Code: HYD2U48IAS
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT