COSOPT PF
These highlights do not include all the information needed to use COSOPT PF safely and effectively. See full prescribing information for COSOPT PF. COSOPT® PF (dorzolamide hydrochloride-timolol maleate ophthalmic solution) 2%/0.5% Initial U.S. Approval: 1998
Approved
Approval ID
535fc801-8c3f-4974-a120-3eff1d5a5062
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 8, 2024
Manufacturers
FDA
Thea Pharma Inc.
DUNS: 117787029
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 Code82584-604
Application NumberNDA202667
Product Classification
M
Marketing Category
C73594
G
Generic Name
dorzolamide hydrochloride and timolol maleate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 8, 2024
FDA Product Classification
INGREDIENTS (7)
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DORZOLAMIDE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: QZO5366EW7
Classification: ACTIM
TIMOLOL MALEATEActive
Quantity: 5 mg in 1 mL
Code: P8Y54F701R
Classification: ACTIM