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FDA Product

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN

Product approved by U.S. Food and Drug Administration (US)

Basic Information

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN

54868-6253

Regulatory Information

54868-6253

ANDA064047

C73584

May 4, 2011

USA

Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution USP (Sterile)

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

194123980

Active Ingredients

NEOMYCIN SULFATE

Quantity: 1.75 mg in 1 mL

Code: 057Y626693

Class Code: ACTIB

POLYMYXIN B SULFATE

Quantity: 10000 [USP'U] in 1 mL

Code: 19371312D4

Class Code: ACTIB

GRAMICIDIN

Quantity: 0.025 mg in 1 mL

Code: 5IE62321P4

Class Code: ACTIB

SODIUM CHLORIDE

Code: 451W47IQ8X

Class Code: IACT

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

POLOXAMER 188

Code: LQA7B6G8JG

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

GRAMICIDIN

Code: 5IE62321P4

NEOMYCIN

Code: I16QD7X297

POLYMYXIN B

Code: J2VZ07J96K

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