Orange Book product · Generic (ANDA)
FONDAPARINUX SODIUM
FONDAPARINUX SODIUM
At a glance
Dec 18, 2024
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 18, 2024
1 yr 6 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
Not listed
Application
ANDA 218312
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of FONDAPARINUX SODIUM
- 2001ARIXTRABrand (NDA)
NDA 021345 · MYLAN IRELAND LTD
- 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.
