BRINZOLAMIDE
These highlights do not include all the information needed to use BRINZOLAMIDE OPHTHALMIC SUSPENSION safely and effectively. See full prescribing information for BRINZOLAMIDE OPHTHALMIC SUSPENSION.BRINZOLAMIDE ophthalmic suspension 1%, for topical ophthalmic useInitial U.S. Approval: 1998
Approved
Approval ID
b56a2e4b-7502-4831-a5b1-0370bdb987b1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 28, 2023
Manufacturers
FDA
Padagis US LLC
DUNS: 967694121
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
brinzolamide
PRODUCT DETAILS
NDC Product Code0574-4012
Application NumberANDA211914
Marketing CategoryC73584
Route of AdministrationOPHTHALMIC
Effective DateJuly 28, 2023
Generic Namebrinzolamide
INGREDIENTS (10)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: HHT01ZNK31
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
BRINZOLAMIDEActive
Quantity: 10 mg in 1 mL
Code: 9451Z89515
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Quantity: 0.1 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT