Timoptic in Ocudose
TIMOPTIC in OCUDOSE 0.25% and 0.5% (timolol maleate ophthalmic solution)
Approved
Approval ID
c1293d51-b633-486c-8e13-fcf60063faeb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 6, 2020
Manufacturers
FDA
Bausch Health US LLC
DUNS: 831922468
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 Code0187-1496
Application NumberNDA019463
Product Classification
M
Marketing Category
C73594
G
Generic Name
Timolol Maleate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 6, 2020
FDA Product Classification
INGREDIENTS (5)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: IACT
Timolol MaleateActive
Quantity: 6.8 mg in 1 mL
Code: P8Y54F701R
Classification: ACTIM
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Timolol Maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0187-1498
Application NumberNDA019463
Product Classification
M
Marketing Category
C73594
G
Generic Name
Timolol Maleate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 6, 2020
FDA Product Classification
INGREDIENTS (5)
TIMOLOL MALEATEActive
Quantity: 3.4 mg in 1 mL
Code: P8Y54F701R
Classification: ACTIM
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT