Timolol Maleate
Timolol Maleate Ophthalmic Solution 0.25% and 0.5%
Approved
Approval ID
9c14ca2d-80f3-48ef-b99a-beafaa728a24
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 30, 2022
Manufacturers
FDA
Bausch & Lomb Americas Inc.
DUNS: 118287629
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 Code82260-813
Application NumberNDA018086
Product Classification
M
Marketing Category
C73605
G
Generic Name
Timolol Maleate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateApril 30, 2022
FDA Product Classification
INGREDIENTS (6)
Timolol MaleateActive
Quantity: 5 mg in 1 mL
Code: P8Y54F701R
Classification: ACTIM
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Benzalkonium ChlorideInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Timolol Maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82260-812
Application NumberNDA018086
Product Classification
M
Marketing Category
C73605
G
Generic Name
Timolol Maleate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateApril 30, 2022
FDA Product Classification
INGREDIENTS (6)
Timolol MaleateActive
Quantity: 2.5 mg in 1 mL
Code: P8Y54F701R
Classification: ACTIM
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Benzalkonium ChlorideInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT