Orange Book product · Brand (NDA)
MEDROL
METHYLPREDNISOLONE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
METHYLPREDNISOLONE
Strength
2MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 011153
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 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 040194 · SANDOZ
- 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.
