Orange Book product · Brand (NDA)
XARELTO
RIVAROXABAN
At a glance
Oct 11, 2018
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 11, 2018
7 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
RIVAROXABAN
Strength
2.5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 022406
Product number
004
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2021XARELTOBrand (NDA)
NDA 215859 · JANSSEN PHARMS
- 2026RIVAROXABANGeneric (ANDA)
ANDA 218427 · APOTEX
- 2026RIVAROXABANGeneric (ANDA)
ANDA 218768 · INVAGEN PHARMS
- 2025RIVAROXABANGeneric (ANDA)
ANDA 208579 · APOTEX
- 2025RIVAROXABANGeneric (ANDA)
ANDA 208546 · MSN
- 2025RIVAROXABANGeneric (ANDA)
ANDA 218195 · LUPIN
- 2025RIVAROXABANGeneric (ANDA)
ANDA 218445 · REGCON HOLDINGS
- 2025RIVAROXABANGeneric (ANDA)
ANDA 218117 · SCIEGEN PHARMS
- 2025RIVAROXABANGeneric (ANDA)
ANDA 218502 · ALKEM LABS LTD
- 2025RIVAROXABANGeneric (ANDA)
ANDA 208220 · BRECKENRIDGE
- 2025RIVAROXABANGeneric (ANDA)
ANDA 216995 · AIPING PHARM INC
- 2025RIVAROXABANGeneric (ANDA)
ANDA 210301 · ALEMBIC
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.
