Dorzolamide and Timolol
These highlights do not include all the information needed to use DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION. Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, for topical ophthalmic useInitial U.S. Approval:1998
Approved
Approval ID
c9ae08c5-275d-44b3-9d1e-5d8fedc21b96
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 28, 2022
Manufacturers
FDA
Leading Pharma, LLC
DUNS: 079575060
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution
PRODUCT DETAILS
NDC Product Code69315-305
Application NumberANDA205295
Marketing CategoryC73584
Route of AdministrationOPHTHALMIC
Effective DateFebruary 28, 2022
Generic NameDorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution
INGREDIENTS (9)
DORZOLAMIDE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: QZO5366EW7
Classification: ACTIM
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)Inactive
Code: ZYD53NBL45
Classification: IACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT
TIMOLOL MALEATEActive
Quantity: 5 mg in 1 mL
Code: P8Y54F701R
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT