Orange Book product · Brand (NDA)
METICORTELONE
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
25MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 010255
Product number
002
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.
- 2008FLO-PREDBrand (NDA)
NDA 022067 · SUN PHARMA CANADA
- —STERANEBrand (NDA)
NDA 011446 · PFIZER
- —ECONOPREDBrand (NDA)
NDA 017468 · HARROW EYE
- —OMNIPREDBrand (NDA)
NDA 017469 · SANDOZ
- —PRED FORTEBrand (NDA)
NDA 017011 · ABBVIE
- —PRED MILDBrand (NDA)
NDA 017100 · 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.
