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FDA Approval

Sofosbuvir and Velpatasvir

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

FDA Approval Summary

Company
Effective Date
May 4, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Sofosbuvir(400 mg in 1 1)
Velpatasvir(100 mg in 1 1)

Products1

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

Sofosbuvir and Velpatasvir

Product Details

NDC Product Code
72626-2701
Application Number
NDA208341
Marketing Category
NDA authorized generic (C73605)
Route of Administration
ORAL
Effective Date
April 30, 2022
Code: WJ6CA3ZU8BClass: ACTIBQuantity: 400 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
Code: KCU0C7RS7ZClass: ACTIBQuantity: 100 mg in 1 1
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8BClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
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