Orange Book product · Generic (ANDA)
PREDNISOLONE
PREDNISOLONE
At a glance
Approved Prior to Jan 1, 1982
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
PREDNISOLONE
Strength
5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 080354
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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
- 2023PREDNISOLONEGeneric (ANDA)
ANDA 215673 · AUROBINDO PHARMA LTD
- 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
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.
