Dorzolamide Hydrochloride and Timolol Maleate ophthalmic
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 Initial U.S. Approval: 1998
Approved
Approval ID
cf0c5cb6-7e40-454b-9f2a-a05832bfa5db
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 13, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-6814
Application NumberANDA204777
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dorzolamide Hydrochloride and Timolol Maleate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateNovember 25, 2021
FDA Product Classification
INGREDIENTS (8)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)Inactive
Code: ZYD53NBL45
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
DORZOLAMIDE HYDROCHLORIDEActive
Quantity: 22.3 mg in 1 mL
Code: QZO5366EW7
Classification: ACTIM
TIMOLOL MALEATEActive
Quantity: 6.8 mg in 1 mL
Code: P8Y54F701R
Classification: ACTIM