timolol maleate
STERILE OPHTHALMIC SOLUTION Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% Rx only
Approved
Approval ID
545b7bee-8d5d-4206-b973-8de3c14d6dfe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 3, 2023
Manufacturers
FDA
Lifestar Pharma LLC
DUNS: 080268943
Products 4
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 Code70756-656
Application NumberANDA078771
Product Classification
M
Marketing Category
C73584
G
Generic Name
timolol maleate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJuly 3, 2023
FDA Product Classification
INGREDIENTS (7)
TIMOLOL MALEATEActive
Quantity: 5 mg in 1 mL
Code: P8Y54F701R
Classification: ACTIM
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SW
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
timolol maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70756-657
Application NumberANDA078771
Product Classification
M
Marketing Category
C73584
G
Generic Name
timolol maleate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJuly 3, 2023
FDA Product Classification
INGREDIENTS (7)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SW
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
TIMOLOL MALEATEActive
Quantity: 5 mg in 1 mL
Code: P8Y54F701R
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
timolol maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70756-654
Application NumberANDA078771
Product Classification
M
Marketing Category
C73584
G
Generic Name
timolol maleate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJuly 3, 2023
FDA Product Classification
INGREDIENTS (7)
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SW
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TIMOLOL MALEATEActive
Quantity: 2.5 mg in 1 mL
Code: P8Y54F701R
Classification: ACTIM
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
timolol maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70756-655
Application NumberANDA078771
Product Classification
M
Marketing Category
C73584
G
Generic Name
timolol maleate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJuly 3, 2023
FDA Product Classification
INGREDIENTS (7)
TIMOLOL MALEATEActive
Quantity: 2.5 mg in 1 mL
Code: P8Y54F701R
Classification: ACTIM
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SW
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT