Orange Book product · Brand (NDA)
FLO-PRED
PREDNISOLONE ACETATE
At a glance
Jan 17, 2008
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 17, 2008
18 yr 8 mo ago
Today
Patent 7799331 expires
Listed drug product patent expiration.
Oct 11, 2028
in 2 yr 4 mo
Patent 7799331 expires
Listed drug product patent expiration.
Oct 11, 2028
in 2 yr 4 mo
Pharmaceutical detail
Active ingredient
PREDNISOLONE ACETATE
Strength
EQ 5MG BASE/5ML
Dosage form
SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 022067
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.
- —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
- 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 (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7799331 | Oct 11, 2028 | in 2 yr 4 mo | ProductU-1068 |
| 7799331 | Oct 11, 2028 | in 2 yr 4 mo | ProductU-139 |

