Orange Book product · Brand (NDA)
PRED MILD
PREDNISOLONE ACETATE
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 ACETATE
Strength
0.12%
Dosage form
SUSPENSION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 017100
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.
- 2008FLO-PREDBrand (NDA)
NDA 022067 · SUN PHARMA CANADA
- —METICORTELONEBrand (NDA)
NDA 010255 · SCHERING
- —STERANEBrand (NDA)
NDA 011446 · PFIZER
- —ECONOPREDBrand (NDA)
NDA 017468 · HARROW EYE
- —OMNIPREDBrand (NDA)
NDA 017469 · SANDOZ
- —PRED FORTEBrand (NDA)
NDA 017011 · ABBVIE
- 2025PREDNISOLONE ACETATEGeneric (ANDA)
ANDA 218256 · AMNEAL
- 2024PREDNISOLONE ACETATEGeneric (ANDA)
ANDA 216935 · LUPIN
- —PREDNISOLONE ACETATEGeneric (ANDA)
ANDA 083738 · BEL MAR
- —PREDNISOLONE ACETATEGeneric (ANDA)
ANDA 084717 · CENT PHARMS
- —PREDNISOLONE ACETATEGeneric (ANDA)
ANDA 083032 · EPIC PHARMA LLC
- —PREDNISOLONE ACETATEGeneric (ANDA)
ANDA 084492 · EPIC PHARMA LLC
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.
