Lamivudine and Zidovudine
These highlights do not include all the information needed to use LAMIVUDINE and ZIDOVUDINE TABLETS safely and effectively. See full prescribing information for LAMIVUDINE and ZIDOVUDINE TABLETS. LAMIVUDINE and ZIDOVUDINE tablets, for oral use Initial U.S. Approval: 1997
Approved
Approval ID
63667952-be01-483e-9887-1d5417e7ec16
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 13, 2023
Manufacturers
FDA
Macleods Pharmaceuticals Limited
DUNS: 862128535
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lamivudine and Zidovudine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33342-003
Application NumberANDA090679
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lamivudine and Zidovudine
Product Specifications
Route of AdministrationORAL
Effective DateJuly 13, 2023
FDA Product Classification
INGREDIENTS (10)
ZIDOVUDINEActive
Quantity: 300 mg in 1 1
Code: 4B9XT59T7S
Classification: ACTIB
LAMIVUDINEActive
Quantity: 150 mg in 1 1
Code: 2T8Q726O95
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT