Emtricitabine and Tenofovir Disoproxil Fumarate
EMTRICITABINE and TENOFOVIR DISOPROXIL FUMARATE tablets, for oral use These highlights do not include all the information needed to use EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS safely and effectively. See full prescribing information for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS. Initial U.S. Approval: 2004
Approved
Approval ID
bec65789-2f4b-134d-e053-2a95a90ab597
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
AvKARE
DUNS: 796560394
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Emtricitabine and Tenofovir Disoproxil Fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42291-439
Application NumberANDA209721
Product Classification
M
Marketing Category
C73584
G
Generic Name
Emtricitabine and Tenofovir Disoproxil Fumarate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (9)
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
EMTRICITABINEActive
Quantity: 200 mg in 1 1
Code: G70B4ETF4S
Classification: ACTIB
TENOFOVIR DISOPROXIL FUMARATEActive
Quantity: 300 mg in 1 1
Code: OTT9J7900I
Classification: ACTIB
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT