ZIAGEN
These highlights do not include all the information needed to use ZIAGEN safely and effectively. See full prescribing information for ZIAGEN. ZIAGEN (abacavir sulfate) Tablets and Oral SolutionInitial U.S. Approval: 1998
Approved
Approval ID
ff62bcaa-a200-4ebf-a9ca-1ab2c254751c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 13, 2010
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
abacavir sulfate
PRODUCT DETAILS
NDC Product Code53808-0811
Application NumberNDA020977
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateApril 13, 2010
Generic Nameabacavir sulfate
INGREDIENTS (10)
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
ABACAVIR SULFATEActive
Quantity: 300 mg in 1 1
Code: J220T4J9Q2
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT