Orange Book product · Generic (ANDA)
SORAFENIB TOSYLATE
SORAFENIB TOSYLATE
At a glance
Jan 27, 2025
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 27, 2025
1 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
SORAFENIB TOSYLATE
Strength
EQ 200MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 212228
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of SORAFENIB TOSYLATE
- 2005NEXAVARBrand (NDA)
NDA 021923 · BAYER HLTHCARE
- 2023SORAFENIB TOSYLATEGeneric (ANDA)
ANDA 217095 · TORRENT
- 2022SORAFENIB TOSYLATEGeneric (ANDA)
ANDA 209050 · YABAO PHARM
- 2022SORAFENIB TOSYLATEGeneric (ANDA)
ANDA 216073 · DR REDDYS
- 2020SORAFENIB TOSYLATEGeneric (ANDA)
ANDA 209567 · TEVA PHARMS USA INC
- 2020SORAFENIB TOSYLATEGeneric (ANDA)
ANDA 207012 · MYLAN
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.
