Orange Book product · Generic (ANDA)
PREDNISOLONE ACETATE
PREDNISOLONE ACETATE
At a glance
Jun 11, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 11, 2025
1 yr ago
Today
Pharmaceutical detail
Active ingredient
PREDNISOLONE ACETATE
Strength
1%
Dosage form
SUSPENSION/DROPS
Route
OPHTHALMIC
TE code
AB
Application
ANDA 218256
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of PREDNISOLONE ACETATE
- 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
- —PRED MILDBrand (NDA)
NDA 017100 · ABBVIE
- 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.
