TENOFOVIR DISOPROXIL FUMARATE
These highlights do not include all the information needed to use TENOFOVIR DISOPROXIL FUMARATE TABLETS safely and effectively. See full prescribing information for TENOFOVIR DISOPROXIL FUMARATE TABLETS. TENOFOVIR DISOPROXIL FUMARATE tablets, for oral useInitial U.S. Approval Date: 2001
Approved
Approval ID
bcd3120b-60f6-41d8-a512-ed4a62c836b4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2019
Manufacturers
FDA
Strides Pharma Science Limited
DUNS: 650738743
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tenofovir disoproxil fumarate
PRODUCT DETAILS
NDC Product Code64380-714
Application NumberANDA090742
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 1, 2019
Generic Nametenofovir disoproxil fumarate
INGREDIENTS (9)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TENOFOVIR DISOPROXIL FUMARATEActive
Quantity: 300 mg in 1 1
Code: OTT9J7900I
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT