Dorzolamide and Timolol
Dorzolamide hydrochloride and timolol maleate ophthalmic solution
Approved
Approval ID
3189b866-d8ba-4ffc-a51b-20a46ce9c361
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 15, 2019
Manufacturers
FDA
FDC Limited
DUNS: 650441301
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 Code55545-1007
Application NumberANDA205295
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dorzolamide Hydrochloride and Timolol Maleate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateNovember 15, 2019
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
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)Inactive
Code: ZYD53NBL45
Classification: IACT
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 11/15/2019