tolvaptan
These highlights do not include all the information needed to use TOLVAPTAN TABLETS safely and effectively. See full prescribing information for TOLVAPTAN TABLETS. TOLVAPTAN tablets, for oral use Initial U.S. Approval: 2009
Approved
Approval ID
d9fd11d0-4269-12fb-95cf-b3c11d75e479
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2023
Manufacturers
FDA
Apotex Corp.
DUNS: 845263701
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tolvaptan
PRODUCT DETAILS
NDC Product Code60505-4317
Application NumberANDA207605
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 15, 2023
Generic Nametolvaptan
INGREDIENTS (7)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
TOLVAPTANActive
Quantity: 15 mg in 1 1
Code: 21G72T1950
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
tolvaptan
PRODUCT DETAILS
NDC Product Code60505-4318
Application NumberANDA207605
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 15, 2023
Generic Nametolvaptan
INGREDIENTS (7)
TOLVAPTANActive
Quantity: 30 mg in 1 1
Code: 21G72T1950
Classification: ACTIB
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT