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 LAMIVUDINE tablets, for oral use Initial U.S. Approval: 2004
Approved
Approval ID
d12e80eb-906c-4932-bb03-b4060ba1d31c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 2, 2023
Manufacturers
FDA
Laurus Labs Limited
DUNS: 915075687
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42385-962
Application NumberANDA216332
Product Classification
M
Marketing Category
C73584
G
Generic Name
Abacavir and Lamivudine
Product Specifications
Route of AdministrationORAL
Effective DateJuly 3, 2023
FDA Product Classification
INGREDIENTS (11)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
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
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT