Orange Book product · Generic (ANDA)
REGADENOSON
REGADENOSON
At a glance
Aug 05, 2024
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 05, 2024
1 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
REGADENOSON
Strength
0.4MG/5ML (0.08MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
ANDA 215955
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of REGADENOSON
- 2008LEXISCANBrand (NDA)
NDA 022161 · ASTELLAS
- 2024REGADENOSONGeneric (ANDA)
ANDA 218054 · INDIES PHARMA
- 2023REGADENOSONGeneric (ANDA)
ANDA 217455 · BAXTER HLTHCARE CORP
- 2023REGADENOSONGeneric (ANDA)
ANDA 213856 · MYLAN
- 2023REGADENOSONGeneric (ANDA)
ANDA 215827 · HIKMA
- 2022REGADENOSONGeneric (ANDA)
ANDA 216437 · EUGIA PHARMA
- 2022REGADENOSONGeneric (ANDA)
ANDA 214349 · HOSPIRA
- 2022REGADENOSONGeneric (ANDA)
ANDA 207320 · GLAND
- 2022REGADENOSONGeneric (ANDA)
ANDA 214252 · IMS LTD
- 2022REGADENOSONGeneric (ANDA)
ANDA 213236 · ACCORD HLTHCARE
- 2022REGADENOSONGeneric (ANDA)
ANDA 207604 · APOTEX
- 2022REGADENOSONGeneric (ANDA)
ANDA 213210 · DR REDDYS
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.
