Orange Book product · Brand (NDA)
ARIXTRA
FONDAPARINUX SODIUM
At a glance
Dec 07, 2001
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 07, 2001
24 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
FONDAPARINUX SODIUM
Strength
2.5MG/0.5ML (2.5MG/0.5ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
TE code
AP
Application
NDA 021345
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.
- 2024FONDAPARINUX SODIUMGeneric (ANDA)
ANDA 218312 · BRIGHTGENE
- 2024FONDAPARINUX SODIUMGeneric (ANDA)
ANDA 216493 · HANGZHOU ZHONGMEI
- 2018FONDAPARINUX SODIUMGeneric (ANDA)
ANDA 208615 · SCINOPHARM TAIWAN
- 2018FONDAPARINUX SODIUMGeneric (ANDA)
ANDA 206812 · HENGRUI PHARMA
- 2017FONDAPARINUX SODIUMGeneric (ANDA)
ANDA 206918 · EUGIA PHARMA
- 2011FONDAPARINUX SODIUMGeneric (ANDA)
ANDA 091316 · DR REDDYS LABS LTD
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.
