Orange Book product · Brand (NDA)
XARELTO
RIVAROXABAN
At a glance
Dec 20, 2021
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 20, 2021
4 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
RIVAROXABAN
Strength
1MG/ML
Dosage form
FOR SUSPENSION
Route
ORAL
TE code
AB
Application
NDA 215859
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2018XARELTOBrand (NDA)
NDA 022406 · 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.
