Orange Book product · Generic (ANDA)
PREDNISOLONE SODIUM PHOSPHATE
PREDNISOLONE SODIUM PHOSPHATE
At a glance
Oct 24, 1991
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 24, 1991
35 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
PREDNISOLONE SODIUM PHOSPHATE
Strength
EQ 0.11% PHOSPHATE
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
ANDA 081043
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of PREDNISOLONE SODIUM PHOSPHATE
- 2006ORAPRED ODTBrand (NDA)
NDA 021959 · ADVANZ PHARMA
- 1986PEDIAPREDBrand (NDA)
NDA 019157 · PAI HOLDINGS
- —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
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.
