Adefovir dipivoxil
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . tablets, for oral use Initial U.S. Approval: 2002
Approved
Approval ID
08e07fae-3191-b6a3-c894-d3a8cc53923f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2023
Manufacturers
FDA
Apotex Corp.
DUNS: 845263701
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
adefovir dipivoxil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-3947
Application NumberANDA205459
Product Classification
M
Marketing Category
C73584
G
Generic Name
adefovir dipivoxil
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2023
FDA Product Classification
INGREDIENTS (6)
ADEFOVIR DIPIVOXILActive
Quantity: 10 mg in 1 1
Code: U6Q8Z01514
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT