Dorzolamide Hydrochloride and Timolol Maleate
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 MALEATEophthalmic solution, for topical ophthalmic useInitial U.S. Approval: 1998
Approved
Approval ID
78f39126-3e3b-4633-a4e0-c1f09a794eec
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 31, 2021
Manufacturers
FDA
Sandoz Inc
DUNS: 005387188
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
NDC Product Code61314-030
Application NumberANDA090604
Marketing CategoryC73584
Route of AdministrationOPHTHALMIC
Effective DateSeptember 28, 2017
Generic NameDorzolamide Hydrochloride and Timolol Maleate
INGREDIENTS (8)
DORZOLAMIDE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: QZO5366EW7
Classification: ACTIM
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
Hydroxyethyl Cellulose (2000 Mpa.s At 1%)Inactive
Code: S38J6RZN16
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TIMOLOL MALEATEActive
Quantity: 5 mg in 1 mL
Code: P8Y54F701R
Classification: ACTIM