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FDA Approval

Neomycin Polymyxin B Sulfates and Dexamethasone

Companymedsource pharmaceuticals (DUNS: 833685915)

Effective Date

December 26, 2018

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Neomycin(3.5 mg in 1 mL)

Dexamethasone(1 mg in 1 mL)

Polymyxin B(10000 [USP'U] in 1 mL)

Manufacturing Establishments (1)

medsource pharmaceuticals

Labeler

medsource pharmaceuticals

DUNS Number

833685915

Products (1)

Neomycin Polymyxin B Sulfates and Dexamethasone

NDC Product Code

45865-796

Application Number

ANDA064135

Marketing Category

ANDA (C73584)

Route of Administration

OPHTHALMIC

Effective Date

December 26, 2018

Ingredients

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

POLYSORBATE 20Inactive

Code: 7T1F30V5YHClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

BENZALKONIUM CHLORIDEInactive

Code: F5UM2KM3W7Class: IACT

Code: 057Y626693Class: ACTIMQuantity: 3.5 mg in 1 mL

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

DexamethasoneActive

Code: 7S5I7G3JQLClass: ACTIBQuantity: 1 mg in 1 mL

Polymyxin BActive

Code: 19371312D4Class: ACTIMQuantity: 10000 [USP'U] in 1 mL

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