Registrants (1)
DIRECT RX
079254320
Manufacturing Establishments (1)
DIRECT RX
DIRECT RX
DIRECT RX
079254320
Products (1)
PREDNISOLONE ACETATE
72189-055
NDA017469
NDA (C73594)
OPHTHALMIC
October 30, 2019
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7Class: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74Class: IACT
Prednisolone acetateActive
Code: 8B2807733DClass: ACTIBQuantity: 10 mg in 1 mL
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT