Timolol Maleate
STERILE OPHTHALMIC GEL FORMING SOLUTION
Approved
Approval ID
1f886442-2781-4be4-b20d-d22c2c209790
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 22, 2021
Manufacturers
FDA
Bausch & Lomb Incorporated
DUNS: 196603781
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Timolol Maleate
PRODUCT DETAILS
NDC Product Code24208-818
Application NumberNDA020330
Marketing CategoryC73605
Route of AdministrationOPHTHALMIC
Effective DateFebruary 22, 2021
Generic NameTimolol Maleate
INGREDIENTS (6)
Timolol MaleateActive
Quantity: 2.5 mg in 1 mL
Code: P8Y54F701R
Classification: ACTIM
GELLAN GUM (LOW ACYL)Inactive
Code: 7593U09I4D
Classification: IACT
Benzododecinium BromideInactive
Code: IRY12B2TQ6
Classification: IACT
MannitolInactive
Code: 3OWL53L36A
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
TromethamineInactive
Code: 023C2WHX2V
Classification: IACT
Timolol Maleate
PRODUCT DETAILS
NDC Product Code24208-819
Application NumberNDA020330
Marketing CategoryC73605
Route of AdministrationOPHTHALMIC
Effective DateFebruary 22, 2021
Generic NameTimolol Maleate
INGREDIENTS (6)
TromethamineInactive
Code: 023C2WHX2V
Classification: IACT
Timolol MaleateActive
Quantity: 5 mg in 1 mL
Code: P8Y54F701R
Classification: ACTIM
GELLAN GUM (LOW ACYL)Inactive
Code: 7593U09I4D
Classification: IACT
MannitolInactive
Code: 3OWL53L36A
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Benzododecinium BromideInactive
Code: IRY12B2TQ6
Classification: IACT