Dorzolamide Hydrochloride and Timolol Maleate

Basic Information

Product Name

FDA Product Code

54868-5982

Regulatory Information

NDC Product Code

54868-5982

Application Number

ANDA077847

Marketing Category

C73584

Effective Date

January 25, 2011

Territorial Authority

USA

FDA Title

Dorzolamide Hydrochloride - Timolol Maleate Ophthalmic Solution Sterile Ophthalmic Solution

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

DORZOLAMIDE HYDROCHLORIDE

Quantity: 20 mg in 1 mL

Code: QZO5366EW7

Class Code: ACTIM

HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)

Code: S38J6RZN16

Class Code: IACT

TIMOLOL MALEATE

Quantity: 5 mg in 1 mL

Code: P8Y54F701R

Class Code: ACTIM

BENZALKONIUM CHLORIDE

Code: F5UM2KM3W7

Class Code: IACT

MANNITOL

Code: 3OWL53L36A

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

SODIUM CITRATE

Code: 1Q73Q2JULR

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

Active Moieties

DORZOLAMIDE

Code: 9JDX055TW1

TIMOLOL

Code: 817W3C6175

Basic Information

Regulatory Information

Company Information

Active Ingredients

HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)

BENZALKONIUM CHLORIDE

MANNITOL

WATER

SODIUM CITRATE

SODIUM HYDROXIDE

Active Moieties

DORZOLAMIDE

TIMOLOL