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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0574-4012
Application NumberANDA211914
Product Classification
M
Marketing Category
C73584
G
Generic Name
brinzolamide
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJuly 28, 2023
FDA Product Classification
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