Dorzolamide Hydrochloride
These highlights do not include all the information needed to use DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP safely and effectively. See full prescribing information for DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP. DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 2% for topical ophthalmic use Initial U.S. Approval: 1994
Approved
Approval ID
462a61b2-1ec6-4d18-bc6b-fc03e027caa0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 8, 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.
Dorzolamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code14445-404
Application NumberANDA202053
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dorzolamide
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateAugust 1, 2021
FDA Product Classification
INGREDIENTS (8)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
DORZOLAMIDE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: QZO5366EW7
Classification: ACTIM
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
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