DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALETAE
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
0b75a79a-e048-4bf1-b02b-a72a8b8a0b3b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 16, 2021
Manufacturers
FDA
Indoco Remedies Limited
DUNS: 650445950
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ddorzolamide hydrochloride timolol maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code14445-405
Application NumberANDA202054
Product Classification
M
Marketing Category
C73584
G
Generic Name
ddorzolamide hydrochloride timolol maleate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMay 14, 2021
FDA Product Classification
INGREDIENTS (9)
DORZOLAMIDE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: QZO5366EW7
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
TIMOLOL MALEATEActive
Quantity: 5 mg in 1 mL
Code: P8Y54F701R
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)Inactive
Code: ZYD53NBL45
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT