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 MALEATE ophthalmic solution, for topical ophthalmic use.Initial U.S. Approval: 1998
Approved
Approval ID
17f04726-725f-4839-911d-47fc5e02baae
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2023
Manufacturers
FDA
Somerset Therapeutics, LLC
DUNS: 079947873
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 Code70069-051
Application NumberANDA207523
Product Classification
M
Marketing Category
C73584
G
Generic Name
DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateDecember 18, 2023
FDA Product Classification
INGREDIENTS (8)
DORZOLAMIDE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: QZO5366EW7
Classification: ACTIM
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
TIMOLOL MALEATEActive
Quantity: 5 mg in 1 mL
Code: P8Y54F701R
Classification: ACTIM
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT