Orange Book product · Generic (ANDA)
REGADENOSON
REGADENOSON
At a glance
May 23, 2023
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 23, 2023
3 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
REGADENOSON
Strength
0.4MG/5ML (0.08MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
ANDA 217455
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of REGADENOSON
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ANDA 215955 · GE HEALTHCARE
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ANDA 213856 · MYLAN
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ANDA 215827 · HIKMA
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ANDA 216437 · EUGIA PHARMA
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ANDA 214349 · HOSPIRA
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ANDA 207320 · GLAND
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ANDA 214252 · IMS LTD
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ANDA 213236 · ACCORD HLTHCARE
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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.
