COSOPT

Basic Information

Product Name

COSOPT

FDA Product Code

82584-605

Regulatory Information

NDC Product Code

82584-605

Application Number

NDA020869

Marketing Category

C73594

Effective Date

September 5, 2023

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use COSOPT safely and effectively. See full prescribing information for COSOPT. COSOPT (dorzolamide hydrochloride and timolol maleate ophthalmic solution), for topical ophthalmic use Initial U.S. Approval: 1998

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)

Code: S38J6RZN16

Class Code: IACT

MANNITOL

Code: 3OWL53L36A

Class Code: IACT

SODIUM CITRATE, UNSPECIFIED FORM

Code: 1Q73Q2JULR

Class Code: IACT

BENZALKONIUM CHLORIDE

Code: F5UM2KM3W7

Class Code: IACT

TIMOLOL MALEATE

Quantity: 5 mg in 1 mL

Code: P8Y54F701R

Class Code: ACTIM

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

DORZOLAMIDE HYDROCHLORIDE

Quantity: 20 mg in 1 mL

Code: QZO5366EW7

Class Code: ACTIM

Active Moieties

DORZOLAMIDE

Code: 9JDX055TW1

TIMOLOL ANHYDROUS

Code: 5JKY92S7BR

Basic Information

Regulatory Information

Company Information

Active Ingredients

HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)

MANNITOL

SODIUM CITRATE, UNSPECIFIED FORM

BENZALKONIUM CHLORIDE

SODIUM HYDROXIDE

WATER

Active Moieties

DORZOLAMIDE

TIMOLOL ANHYDROUS