Orange Book product · Brand (NDA)
SOLU-MEDROL
METHYLPREDNISOLONE SODIUM SUCCINATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
METHYLPREDNISOLONE SODIUM SUCCINATE
Strength
EQ 500MG BASE/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 011856
Product number
005
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2022METHYLPREDNISOLONE SODIUM SUCCINATEGeneric (ANDA)
ANDA 203125 · HIKMA
- 2021METHYLPREDNISOLONE SODIUM SUCCINATEGeneric (ANDA)
ANDA 212396 · TIANJIN KINGYORK
- 2016METHYLPREDNISOLONE SODIUM SUCCINATEGeneric (ANDA)
ANDA 207549 · AMNEAL
- 2016METHYLPREDNISOLONE SODIUM SUCCINATEGeneric (ANDA)
ANDA 202691 · HIKMA
- 2015METHYLPREDNISOLONE SODIUM SUCCINATEGeneric (ANDA)
ANDA 207667 · EUGIA PHARMA
- 2011METHYLPREDNISOLONE SODIUM SUCCINATEGeneric (ANDA)
ANDA 040888 · SAGENT PHARMS INC
- 2008A-METHAPREDGeneric (ANDA)
ANDA 040793 · HOSPIRA INC
- 2008A-METHAPREDGeneric (ANDA)
ANDA 040827 · HOSPIRA INC
- 2007METHYLPREDNISOLONE SODIUM SUCCINATEGeneric (ANDA)
ANDA 040641 · BEDFORD LABS
- 2007METHYLPREDNISOLONE SODIUM SUCCINATEGeneric (ANDA)
ANDA 040709 · BEDFORD LABS
- 2007METHYLPREDNISOLONE SODIUM SUCCINATEGeneric (ANDA)
ANDA 040662 · BEDFORD LABS
- 2005A-METHAPREDGeneric (ANDA)
ANDA 040664 · HOSPIRA
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.

