Sofosbuvir and Velpatasvir
These highlights do not include all the information needed to use SOFOSBUVIR and VELPATASVIR TABLETS safely and effectively. See full prescribing information for SOFOSBUVIR and VELPATASVIR TABLETS. SOFOSBUVIR and VELPATASVIR tablets, for oral use, 400 mg/100 mg (Authorized generic of EPCLUSA) Initial U.S. Approval: 2016
Approved
Approval ID
d0c1a945-4440-4b5c-81aa-693ed3db597c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 4, 2022
Manufacturers
FDA
Asegua Therapeutics LLC
DUNS: 116670954
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Velpatasvir and Sofosbuvir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72626-2701
Application NumberNDA208341
Product Classification
M
Marketing Category
C73605
G
Generic Name
Velpatasvir and Sofosbuvir
Product Specifications
Route of AdministrationORAL
Effective DateApril 30, 2022
FDA Product Classification
INGREDIENTS (13)
SOFOSBUVIRActive
Quantity: 400 mg in 1 1
Code: WJ6CA3ZU8B
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
VELPATASVIRActive
Quantity: 100 mg in 1 1
Code: KCU0C7RS7Z
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT