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FDA Approval

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FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Gilead Sciences, Inc.
DUNS: 185049848
Effective Date
December 18, 2020
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Velpatasvir(100 mg in 1 1)
Sofosbuvir(400 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Epclusa Access

Product Details

NDC Product Code
61958-2202
Route of Administration
ORAL
Effective Date
December 18, 2020
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8BClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
Code: KCU0C7RS7ZClass: ACTIBQuantity: 100 mg in 1 1
Code: WJ6CA3ZU8BClass: ACTIBQuantity: 400 mg in 1 1
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