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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

24208-790

Regulatory Information

24208-790

ANDA064047

C73584

August 2, 2022

USA

Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution, USP

HUMAN PRESCRIPTION DRUG LABEL

10

Company Information

196603781

Active Ingredients

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

SODIUM CHLORIDE

Code: 451W47IQ8X

Class Code: IACT

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

POLOXAMER 188

Code: LQA7B6G8JG

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

NEOMYCIN SULFATE

Quantity: 1.75 mg in 1 mL

Code: 057Y626693

Class Code: ACTIM

POLYMYXIN B SULFATE

Quantity: 10000 [USP'U] in 1 mL

Code: 19371312D4

Class Code: ACTIM

GRAMICIDIN

Quantity: 0.025 mg in 1 mL

Code: 5IE62321P4

Class Code: ACTIB

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

THIMEROSAL

Quantity: 0.01 mg in 1 mL

Code: 2225PI3MOV

Class Code: IACT

Active Moieties

GRAMICIDIN

Code: 5IE62321P4

NEOMYCIN

Code: I16QD7X297

POLYMYXIN B

Code: J2VZ07J96K

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