TIMOLOL MALEATE
STERILE OPHTHALMIC SOLUTION TIMOLOL MALEATEOPHTHALMIC SOLUTIONUSP 0.25% AND 0.5%
Approved
Approval ID
42887224-997c-4f08-8e2c-918de7195a6e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 21, 2017
Manufacturers
FDA
FDC Limited
DUNS: 650441301
Products 1
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 Code55545-1001
Application NumberANDA077259
Product Classification
M
Marketing Category
C73584
G
Generic Name
timolol maleate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateNovember 21, 2017
FDA Product Classification
INGREDIENTS (7)
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATEInactive
Code: E1W4N241FO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
TIMOLOL MALEATEActive
Quantity: 5 mg in 1 mL
Code: P8Y54F701R
Classification: ACTIM
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEInactive
Code: 5QWK665956
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Quantity: 0.1 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT