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
92ce12f1-eae0-4c83-9a4e-a5181e08fa92
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 14, 2023
Manufacturers
FDA
Novadoz Pharmaceuticals LLC
DUNS: 081109687
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 Code72205-131
Application NumberANDA216949
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 31, 2023
Generic NameTOLVAPTAN
INGREDIENTS (8)
TOLVAPTANActive
Quantity: 30 mg in 1 1
Code: 21G72T1950
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C BLUE NO. 2 ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TOLVAPTAN
PRODUCT DETAILS
NDC Product Code72205-130
Application NumberANDA216949
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 31, 2023
Generic NameTOLVAPTAN
INGREDIENTS (8)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TOLVAPTANActive
Quantity: 15 mg in 1 1
Code: 21G72T1950
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 2 ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT