MedPath
FDA Approval

NEO-POLY-DEX

November 3, 2010

HUMAN PRESCRIPTION DRUG LABEL

Dexamethasone(1 mg in 1 mL)
Neomycin(3.5 mg in 1 mL)
Polymyxin B(10000 [USP'U] in 1 mL)

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

Code: 7S5I7G3JQLClass: ACTIBQuantity: 1 mg in 1 mL
NeomycinActive
Code: 057Y626693Class: ACTIBQuantity: 3.5 mg in 1 mL
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
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