Timolol GFS
These highlights do not include all the information needed to use Timolol GFS safely and effectively. See full prescribing information for Timolol GFS.Timolol GFS (timolol maleate ophthalmic gel forming solution) 0.25% and 0.5%, Sterile topical ophthalmic dropsInitial U.S. Approval: 1978
Approved
Approval ID
72b0d0ec-832a-4c25-b845-2537ab506354
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 31, 2008
Manufacturers
FDA
Sandoz Inc
DUNS: 005387188
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 Code61314-225
Application NumberNDA020963
Product Classification
M
Marketing Category
C73594
G
Generic Name
timolol maleate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateDecember 31, 2008
FDA Product Classification
INGREDIENTS (8)
BENZODODECINIUM BROMIDEInactive
Code: IRY12B2TQ6
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
TIMOLOL MALEATEActive
Quantity: 5 mg in 1 mL
Code: P8Y54F701R
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
timolol maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61314-224
Application NumberNDA020963
Product Classification
M
Marketing Category
C73594
G
Generic Name
timolol maleate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateDecember 31, 2008
FDA Product Classification
INGREDIENTS (8)
TIMOLOL MALEATEActive
Quantity: 2.5 mg in 1 mL
Code: P8Y54F701R
Classification: ACTIM
BENZODODECINIUM BROMIDEInactive
Code: IRY12B2TQ6
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT