Orange Book product · Generic (ANDA)
METHYLPREDNISOLONE ACETATE
METHYLPREDNISOLONE ACETATE
At a glance
May 20, 2019
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 20, 2019
7 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
METHYLPREDNISOLONE ACETATE
Strength
80MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AB
Application
ANDA 210043
Product number
002
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of METHYLPREDNISOLONE ACETATE
- —MEDROLBrand (NDA)
NDA 018102 · PHARMACIA AND UPJOHN
- —DEPO-MEDROLBrand (NDA)
NDA 011757 · PFIZER
- —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
- 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.
