Orange Book product · Generic (ANDA)
SOFOSBUVIR
SOFOSBUVIR
Generic (ANDA)ANDA 211353DISCN TEVA PHARMS USA INC
At a glance
Jan 27, 2022
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 27, 2022
4 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
SOFOSBUVIR
Strength
400MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 211353
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of SOFOSBUVIR
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
