Abacavir and Lamivudine
These highlights do not include all the information needed to use ABACAVIR AND LAMIVUDINE TABLETS safely and effectively. See full prescribing information for ABACAVIR AND LAMIVUDINE TABLETS ABACAVIR and LAMIVUIDNE Tablets, for oral useInitial U.S. Approval:2004
Approved
Approval ID
c0488bee-2f18-4e2e-8e11-68543c023dec
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2022
Manufacturers
FDA
Cipla USA Inc.
DUNS: 078719707
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Abacavir and lamivudine
PRODUCT DETAILS
NDC Product Code69097-362
Application NumberANDA091144
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 18, 2022
Generic NameAbacavir and lamivudine
INGREDIENTS (12)
SODIUM STARCH GLYCOLATE TYPE B POTATOInactive
Code: 27NA468985
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ABACAVIR SULFATEActive
Quantity: 600 mg in 1 1
Code: J220T4J9Q2
Classification: ACTIM
LAMIVUDINEActive
Quantity: 300 mg in 1 1
Code: 2T8Q726O95
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT