Orange Book product · Brand (NDA)
JADENU SPRINKLE
DEFERASIROX
At a glance
May 18, 2017
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 18, 2017
9 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
DEFERASIROX
Strength
360MG
Dosage form
GRANULE
Route
ORAL
TE code
AB
Application
NDA 207968
Product number
003
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.
- 2015JADENUBrand (NDA)
NDA 206910 · NOVARTIS PHARMS CORP
- 2005EXJADEBrand (NDA)
NDA 021882 · NOVARTIS
- 2025DEFERASIROXGeneric (ANDA)
ANDA 215137 · AUROBINDO PHARMA
- 2025DEFERASIROXGeneric (ANDA)
ANDA 211660 · JUBILANT GENERICS
- 2024DEFERASIROXGeneric (ANDA)
ANDA 209426 · TORRENT
- 2024DEFERASIROXGeneric (ANDA)
ANDA 206585 · PHARMOBEDIENT
- 2024DEFERASIROXGeneric (ANDA)
ANDA 213146 · PHARMOBEDIENT
- 2024DEFERASIROXGeneric (ANDA)
ANDA 211395 · PHARMOBEDIENT
- 2023DEFERASIROXGeneric (ANDA)
ANDA 214474 · AUROBINDO PHARMA LTD
- 2023DEFERASIROXGeneric (ANDA)
ANDA 216229 · ANNORA PHARMA
- 2022DEFERASIROXGeneric (ANDA)
ANDA 207124 · TEVA PHARMS USA
- 2022DEFERASIROXGeneric (ANDA)
ANDA 214650 · MSN
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.

