Orange Book product · Brand (NDA)
HYDELTRASOL
PREDNISOLONE SODIUM PHOSPHATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
PREDNISOLONE SODIUM PHOSPHATE
Strength
EQ 0.25% PHOSPHATE
Dosage form
OINTMENT
Route
OPHTHALMIC, OTIC
TE code
Not listed
Application
NDA 011028
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 2006ORAPRED ODTBrand (NDA)
NDA 021959 · ADVANZ PHARMA
- 1986PEDIAPREDBrand (NDA)
NDA 019157 · PAI HOLDINGS
- —HYDELTRASOLBrand (NDA)
NDA 011583 · 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.
