Hepsera
These highlights do not include all the information needed to use HEPSERA safely and effectively. See full prescribing information for HEPSERA. HEPSERA (adefovir dipivoxil) tablet for oral use Initial U.S. Approval: 2002
Approved
Approval ID
80595d45-2224-47d1-bd5c-4b11a824e5bd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 27, 2009
Manufacturers
FDA
Excella GmbH
DUNS: 329809800
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 Code46014-0501
Application NumberNDA021449
Product Classification
M
Marketing Category
C73594
G
Generic Name
Adefovir Dipivoxil
Product Specifications
Route of AdministrationORAL
Effective DateOctober 27, 2009
FDA Product Classification
INGREDIENTS (1)
Adefovir DipivoxilActive
Quantity: 10 mg in 1 1
Code: U6Q8Z01514
Classification: ACTIM