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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

21695-528

Regulatory Information

21695-528

ANDA064047

C73584

February 22, 2007

USA

Neomycin and Polymyxin B Sulfatesand Gramicidin Ophthalmic Solution USP

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

118802834

Active Ingredients

Neomycin Sulfate

Quantity: 1.75 mg in 1 mL

Code: 057Y626693

Class Code: ACTIB

Polymyxin B Sulfate

Quantity: 10000 mg in 1 mL

Code: 19371312D4

Class Code: ACTIB

Gramicidin

Quantity: 0.025 mg in 1 mL

Code: 5IE62321P4

Class Code: ACTIB

Hydrochloric Acid

Code: QTT17582CB

Class Code: IACT

Sodium Chloride

Code: 451W47IQ8X

Class Code: IACT

Alcohol

Code: 3K9958V90M

Class Code: IACT

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

POLYETHYLENE GLYCOL

Code: 3WJQ0SDW1A

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

POLOXAMER 188

Code: LQA7B6G8JG

Class Code: IACT

Water

Code: 059QF0KO0R

Class Code: IACT

Thimerosal

Code: 2225PI3MOV

Class Code: IACT

Active Moieties

Neomycin

Code: I16QD7X297

Polymyxin B

Code: J2VZ07J96K

Gramicidin

Code: 5IE62321P4

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