Timolol Maleate
Timolol Maleate
Approved
Approval ID
d591352a-09d8-2fdc-e053-2a95a90ad8a5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 8, 2022
Manufacturers
FDA
Athem LLC
DUNS: 117077124
Products 3
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 Code73152-029
Application NumberANDA207556
Product Classification
M
Marketing Category
C73584
G
Generic Name
Timolol Maleate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 8, 2022
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TIMOLOL MALEATEActive
Quantity: 5 mg in 1 1
Code: P8Y54F701R
Classification: ACTIM
Timolol Maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73152-030
Application NumberANDA207556
Product Classification
M
Marketing Category
C73584
G
Generic Name
Timolol Maleate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 8, 2022
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TIMOLOL MALEATEActive
Quantity: 10 mg in 1 1
Code: P8Y54F701R
Classification: ACTIM
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
Timolol Maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73152-031
Application NumberANDA207556
Product Classification
M
Marketing Category
C73584
G
Generic Name
Timolol Maleate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 8, 2022
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TIMOLOL MALEATEActive
Quantity: 20 mg in 1 1
Code: P8Y54F701R
Classification: ACTIM
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT