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FDA Product

PREDNISOLONE ACETATE

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

Basic Information

PREDNISOLONE ACETATE

50090-1912

Regulatory Information

50090-1912

NDA017011

C73605

January 13, 2023

USA

PREDNISOLONE ACETATE ophthalmic suspension, USP 1% sterile

HUMAN PRESCRIPTION DRUG LABEL

6

Company Information

830016429

Active Ingredients

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

BORIC ACID

Code: R57ZHV85D4

Class Code: IACT

PREDNISOLONE ACETATE

Quantity: 10 mg in 1 mL

Code: 8B2807733D

Class Code: ACTIB

BENZALKONIUM CHLORIDE

Code: F5UM2KM3W7

Class Code: IACT

EDETATE DISODIUM

Code: 7FLD91C86K

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

SODIUM BISULFITE

Code: TZX5469Z6I

Class Code: IACT

SODIUM CHLORIDE

Code: 451W47IQ8X

Class Code: IACT

SODIUM CITRATE, UNSPECIFIED FORM

Code: 1Q73Q2JULR

Class Code: IACT

Active Moieties

PREDNISOLONE

Code: 9PHQ9Y1OLM

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