Orange Book product · Generic (ANDA)
METHYLPREDNISOLONE
METHYLPREDNISOLONE
At a glance
Oct 31, 1997
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 31, 1997
29 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
METHYLPREDNISOLONE
Strength
4MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 040194
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of METHYLPREDNISOLONE
- —MEDROLBrand (NDA)
NDA 011153 · PFIZER
- 2021METHYLPREDNISOLONEGeneric (ANDA)
ANDA 207481 · AMNEAL
- 2019METHYLPREDNISOLONEGeneric (ANDA)
ANDA 212262 · PRAXGEN
- 2019METHYLPREDNISOLONEGeneric (ANDA)
ANDA 209097 · CHARTWELL RX
- 2019METHYLPREDNISOLONEGeneric (ANDA)
ANDA 210985 · INGENUS PHARMS LLC
- 2018METHYLPREDNISOLONEGeneric (ANDA)
ANDA 204072 · TIANJIN TIANYAO
- 2018METHYLPREDNISOLONEGeneric (ANDA)
ANDA 206751 · ZYDUS PHARMS
- 1998METHYLPREDNISOLONEGeneric (ANDA)
ANDA 040183 · PH HEALTH
- 1997METHYLPREDNISOLONEGeneric (ANDA)
ANDA 040189 · JUBILANT CADISTA
- 1997METHYLPREDNISOLONEGeneric (ANDA)
ANDA 040232 · WATSON LABS
- 1988METHYLPREDNISOLONEGeneric (ANDA)
ANDA 089207 · PAR PHARM
- 1988METHYLPREDNISOLONEGeneric (ANDA)
ANDA 089208 · PAR PHARM
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.
