BLEPHAMIDE

Manufacturing Establishments (1)

Labeler

Physicians Total Care, Inc.

DUNS Number

194123980

NDC Product Code

54868-0634

Application Number

NDA012813

Marketing Category

NDA (C73594)

Route of Administration

OPHTHALMIC

Effective Date

November 15, 2013

Ingredients

edetate disodiumInactive

Code: 7FLD91C86KClass: IACT

Code: 4NRT660KJQClass: ACTIBQuantity: 100 mg in 1 mL

Code: 8B2807733DClass: ACTIBQuantity: 2 mg in 1 mL

benzalkonium chlorideInactive

Code: F5UM2KM3W7Class: IACT

polyvinyl alcoholInactive

Code: 532B59J990Class: IACT

waterInactive

Code: 059QF0KO0RClass: IACT

potassium phosphate, monobasicInactive

Code: 4J9FJ0HL51Class: IACT

polysorbate 80Inactive

Code: 6OZP39ZG8HClass: IACT

hydrochloric acidInactive

Code: QTT17582CBClass: IACT

sodium phosphate, dibasicInactive

Code: GR686LBA74Class: IACT

sodium thiosulfateInactive

Code: HX1032V43MClass: IACT

sodium hydroxideInactive

Code: 55X04QC32IClass: IACT