Orange Book product · Generic (ANDA)
PREDNISONE
PREDNISONE
At a glance
Dec 05, 2023
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 05, 2023
2 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
PREDNISONE
Strength
5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 212629
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of PREDNISONE
- 2012RAYOSBrand (NDA)
NDA 202020 · HORIZON
- —DELTASONEBrand (NDA)
NDA 009986 · PHARMACIA AND UPJOHN
- —METICORTENBrand (NDA)
NDA 009766 · SCHERING
- —PARACORTBrand (NDA)
NDA 010962 · PARKE DAVIS
- 2025PREDNISONEGeneric (ANDA)
ANDA 219477 · DR REDDYS
- 2022PREDNISONEGeneric (ANDA)
ANDA 215672 · AUROBINDO PHARMA LTD
- 2021PREDNISONEGeneric (ANDA)
ANDA 215671 · AUROBINDO PHARMA LTD
- 2020PREDNISONEGeneric (ANDA)
ANDA 213386 · AMNEAL
- 2020PREDNISONEGeneric (ANDA)
ANDA 213385 · AMNEAL
- 2018PREDNISONEGeneric (ANDA)
ANDA 211496 · GENEYORK PHARMS
- 2018PREDNISONEGeneric (ANDA)
ANDA 210525 · GENEYORK PHARMS
- 2017PREDNISONEGeneric (ANDA)
ANDA 204867 · ACTAVIS LABS FL INC
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.
