Registrants (1)
Bausch & Lomb Incorporated
196603781
Manufacturing Establishments (1)
Bausch & Lomb Incorporated
Butler Animal Health Supply
Bausch & Lomb Incorporated
807927397
Products (1)
NEO-POLY-DEX
11695-1403
ANDA064135
ANDA (C73584)
OPHTHALMIC
November 14, 2008
DexamethasoneActive
Code: 7S5I7G3JQLClass: ACTIBQuantity: 1 mg in 1 mL
NeomycinActive
Code: 057Y626693Class: ACTIBQuantity: 3.5 mg in 1 mL
Polymyxin BActive
Code: 19371312D4Class: ACTIBQuantity: 10000 [USP'U] in 1 mL
Hydrochloric AcidInactive
Code: QTT17582CBClass: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YHClass: IACT
WaterInactive
Code: 059QF0KO0RClass: IACT
Sodium HydroxideInactive
Code: 55X04QC32IClass: IACT
Sodium ChlorideInactive
Code: 451W47IQ8XClass: IACT