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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24208-818
Application NumberNDA020330
Product Classification
M
Marketing Category
C73605
G
Generic Name
Timolol Maleate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateFebruary 22, 2021
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24208-819
Application NumberNDA020330
Product Classification
M
Marketing Category
C73605
G
Generic Name
Timolol Maleate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateFebruary 22, 2021
FDA Product Classification
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