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
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