Orange Book product · Generic (ANDA)
PRELONE
PREDNISOLONE
At a glance
Jan 17, 1989
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 17, 1989
38 yr ago
Today
Pharmaceutical detail
Active ingredient
PREDNISOLONE
Strength
5MG/5ML
Dosage form
SYRUP
Route
ORAL
TE code
Not listed
Application
ANDA 089654
Product number
001
Marketing status
DISCN
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
- 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.
