Orange Book product · Generic (ANDA)
PREDNISOLONE
PREDNISOLONE
At a glance
Mar 17, 2023
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 17, 2023
3 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
PREDNISOLONE
Strength
5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 215673
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of PREDNISOLONE
- —METI-DERMBrand (NDA)
NDA 010209 · SCHERING
- —DELTA-CORTEFBrand (NDA)
NDA 009987 · PHARMACIA AND UPJOHN
- 2025PREDNISOLONEGeneric (ANDA)
ANDA 219509 · TP ANDA HOLDINGS
- 2007PREDNISOLONEGeneric (ANDA)
ANDA 040775 · LANNETT CO INC
- 2005PREDNISOLONEGeneric (ANDA)
ANDA 040571 · PHARM ASSOC
- 2005PREDNISOLONEGeneric (ANDA)
ANDA 040570 · PHARM ASSOC
- 2003PREDNISOLONEGeneric (ANDA)
ANDA 040313 · PHARMOBEDIENT CNSLTG
- 2003PREDNISOLONEGeneric (ANDA)
ANDA 040399 · PHARM ASSOC
- 2003PREDNISOLONEGeneric (ANDA)
ANDA 040401 · HIKMA
- 2002PREDNISOLONEGeneric (ANDA)
ANDA 040364 · NESHER PHARMS
- 2001PREDNISOLONEGeneric (ANDA)
ANDA 040423 · NESHER PHARMS
- 2000PREDNISOLONEGeneric (ANDA)
ANDA 040322 · TEVA PHARMS
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.
