Orange Book product · Brand (NDA)
DEPO-MEDROL
METHYLPREDNISOLONE ACETATE
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 ACETATE
Strength
20MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 011757
Product number
002
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.
- —MEDROLBrand (NDA)
NDA 018102 · PHARMACIA AND UPJOHN
- —MEDROL ACETATEBrand (NDA)
NDA 012421 · PHARMACIA AND UPJOHN
- 2026METHYLPREDNISOLONE ACETATEGeneric (ANDA)
ANDA 220556 · CAPLIN
- 2025METHYLPREDNISOLONE ACETATEGeneric (ANDA)
ANDA 219145 · HIKMA
- 2023METHYLPREDNISOLONE ACETATEGeneric (ANDA)
ANDA 216502 · AMNEAL
- 2023METHYLPREDNISOLONE ACETATEGeneric (ANDA)
ANDA 214870 · WILSHIRE PHARMS INC
- 2023METHYLPREDNISOLONE ACETATEGeneric (ANDA)
ANDA 211930 · EUGIA PHARMA
- 2022METHYLPREDNISOLONE ACETATEGeneric (ANDA)
ANDA 214297 · PH HEALTH
- 2019METHYLPREDNISOLONE ACETATEGeneric (ANDA)
ANDA 210043 · AMNEAL
- 2018METHYLPREDNISOLONE ACETATEGeneric (ANDA)
ANDA 201835 · SAGENT PHARMS INC
- 2009METHYLPREDNISOLONE ACETATEGeneric (ANDA)
ANDA 040794 · SANDOZ
- 2009METHYLPREDNISOLONE ACETATEGeneric (ANDA)
ANDA 040719 · SANDOZ
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.
