Timolol Maleate Ophthalmic Gel Forming Solution, 0.25%

TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION 0.25% and 0.5%

Approved

Approval ID

b909ecf0-c90a-4719-a144-9e74f457cb87

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 13, 2022

Manufacturers

FDA

Alembic Pharmaceuticals Inc.

DUNS: 079288842

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%

PRODUCT DETAILS

NDC Product Code62332-546

Application NumberANDA212942

Marketing CategoryC73584

Route of AdministrationOPHTHALMIC

Effective DateFebruary 14, 2020

Generic NameTimolol Maleate Ophthalmic Gel Forming Solution, 0.5%

INGREDIENTS (6)

TIMOLOL MALEATEActive

Quantity: 5 mg in 1 mL

Code: P8Y54F701R

Classification: ACTIM

BENZODODECINIUM BROMIDEInactive

Code: IRY12B2TQ6

Classification: IACT

TROMETHAMINEInactive

Code: 023C2WHX2V

Classification: IACT

GELLAN GUM (LOW ACYL)Inactive

Code: 7593U09I4D

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT