Orange Book product · Brand (NDA)
PEDIAPRED
PREDNISOLONE SODIUM PHOSPHATE
At a glance
May 28, 1986
Approved
Brand (NDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 28, 1986
40 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
PREDNISOLONE SODIUM PHOSPHATE
Strength
EQ 5MG BASE/5ML
Dosage form
SOLUTION
Route
ORAL
TE code
AA
Application
NDA 019157
Product number
001
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.
- 2006ORAPRED ODTBrand (NDA)
NDA 021959 · ADVANZ PHARMA
- —HYDELTRASOLBrand (NDA)
NDA 011583 · MERCK
- —HYDELTRASOLBrand (NDA)
NDA 011028 · MERCK
- 2022PREDNISOLONE SODIUM PHOSPHATEGeneric (ANDA)
ANDA 216715 · AMNEAL
- 2020PREDNISOLONE SODIUM PHOSPHATEGeneric (ANDA)
ANDA 204962 · PHARM ASSOC
- 2016PREDNISOLONE SODIUM PHOSPHATEGeneric (ANDA)
ANDA 203559 · EDENBRIDGE PHARMS
- 2013PREDNISOLONE SODIUM PHOSPHATEGeneric (ANDA)
ANDA 202179 · RISING
- 2010PREDNISOLONE SODIUM PHOSPHATEGeneric (ANDA)
ANDA 091396 · MISSION PHARMA
- 2009PREDNISOLONE SODIUM PHOSPHATEGeneric (ANDA)
ANDA 079010 · PH HEALTH
- 2009PREDNISOLONE SODIUM PHOSPHATEGeneric (ANDA)
ANDA 078345 · AMNEAL PHARMS
- 2008PREDNISOLONE SODIUM PHOSPHATEGeneric (ANDA)
ANDA 078988 · PHARM ASSOC
- 2008PREDNISOLONE SODIUM PHOSPHATEGeneric (ANDA)
ANDA 078465 · PHARM ASSOC
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.
