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
NDC Product Code0187-1496
Application NumberNDA019463
Marketing CategoryC73594
Route of AdministrationOPHTHALMIC
Effective DateJanuary 6, 2020
Generic NameTimolol Maleate
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
NDC Product Code0187-1498
Application NumberNDA019463
Marketing CategoryC73594
Route of AdministrationOPHTHALMIC
Effective DateJanuary 6, 2020
Generic NameTimolol Maleate
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