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FDA Orange Book · active-ingredient family

Methylprednisolone sodium succinate

Methylprednisolone sodium succinate is approved as 1 brand and 48 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:SOLU-MEDROL · NDA 011856

1

Brand (NDA)

48

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable

ProductApplicantApplicationTEApproved
SOLU-MEDROLRLD×5PHARMACIA AND UPJOHNNDA 011856APApproved Prior to Jan 1, 1982

Generic (ANDA) products (48)

ProductApplicantApplicationTEApproved
METHYLPREDNISOLONE SODIUM SUCCINATE×2HIKMAANDA 203125APSep 26, 2022
METHYLPREDNISOLONE SODIUM SUCCINATE×5TIANJIN KINGYORKANDA 212396APApr 20, 2021
METHYLPREDNISOLONE SODIUM SUCCINATE×2AMNEALANDA 207549APNov 09, 2016
METHYLPREDNISOLONE SODIUM SUCCINATE×2HIKMAANDA 202691APFeb 16, 2016
METHYLPREDNISOLONE SODIUM SUCCINATE×4EUGIA PHARMAANDA 207667—Dec 15, 2015
METHYLPREDNISOLONE SODIUM SUCCINATE×5SAGENT PHARMS INCANDA 040888APJul 18, 2011
A-METHAPREDHOSPIRA INCANDA 040793—Nov 25, 2008
A-METHAPREDHOSPIRA INCANDA 040827—Nov 25, 2008
METHYLPREDNISOLONE SODIUM SUCCINATE×3BEDFORD LABSANDA 040641—Feb 21, 2007
METHYLPREDNISOLONE SODIUM SUCCINATE×2BEDFORD LABSANDA 040709—Feb 21, 2007
METHYLPREDNISOLONE SODIUM SUCCINATEBEDFORD LABSANDA 040662—Feb 21, 2007
A-METHAPREDHOSPIRAANDA 040664—Dec 20, 2005
A-METHAPREDHOSPIRAANDA 040665—Dec 20, 2005
METHYLPREDNISOLONE SODIUM SUCCINATEFRESENIUS KABI USAANDA 040612APAug 12, 2004
METHYLPREDNISOLONE SODIUM SUCCINATE×2FRESENIUS KABI USAANDA 040583APJul 30, 2004
METHYLPREDNISOLONE SODIUM SUCCINATETEVA PARENTERALANDA 081268—Nov 30, 1992
METHYLPREDNISOLONE SODIUM SUCCINATETEVA PARENTERALANDA 081266—Nov 30, 1992
METHYLPREDNISOLONE SODIUM SUCCINATETEVA PARENTERALANDA 081267—Nov 30, 1992
A-METHAPREDABBOTTANDA 089576—Feb 22, 1991
A-METHAPREDABBOTTANDA 089573—Feb 22, 1991
A-METHAPREDABBOTTANDA 089574—Feb 22, 1991
A-METHAPREDABBOTTANDA 089575—Feb 22, 1991
A-METHAPREDHOSPIRAANDA 089174—Aug 18, 1987
A-METHAPREDHOSPIRAANDA 089173—Aug 18, 1987
METHYLPREDNISOLONE SODIUM SUCCINATEABRAXIS PHARMANDA 089188—Mar 28, 1986
METHYLPREDNISOLONE SODIUM SUCCINATEABRAXIS PHARMANDA 089189—Mar 28, 1986
METHYLPREDNISOLONE SODIUM SUCCINATEABRAXIS PHARMANDA 089143—Mar 28, 1986
METHYLPREDNISOLONE SODIUM SUCCINATEABRAXIS PHARMANDA 089144—Mar 28, 1986
METHYLPREDNISOLONE SODIUM SUCCINATEABRAXIS PHARMANDA 089186—Mar 28, 1986
METHYLPREDNISOLONE SODIUM SUCCINATEABRAXIS PHARMANDA 089187—Mar 28, 1986
METHYLPREDNISOLONE SODIUM SUCCINATEWATSON LABSANDA 088524—Jul 24, 1984
METHYLPREDNISOLONE SODIUM SUCCINATEWATSON LABSANDA 088523—Jul 24, 1984
METHYLPREDNISOLONE SODIUM SUCCINATEABRAXIS PHARMANDA 088679—Jun 08, 1984
METHYLPREDNISOLONE SODIUM SUCCINATEABRAXIS PHARMANDA 088676—Jun 08, 1984
METHYLPREDNISOLONE SODIUM SUCCINATEABRAXIS PHARMANDA 088677—Jun 08, 1984
METHYLPREDNISOLONE SODIUM SUCCINATEABRAXIS PHARMANDA 088678—Jun 08, 1984
METHYLPREDNISOLONE SODIUM SUCCINATEINTL MEDICATIONANDA 087852—Feb 09, 1983
METHYLPREDNISOLONE SODIUM SUCCINATEINTL MEDICATIONANDA 087812—Feb 09, 1983
METHYLPREDNISOLONE SODIUM SUCCINATEINTL MEDICATIONANDA 087813—Feb 09, 1983
METHYLPREDNISOLONE SODIUM SUCCINATEINTL MEDICATIONANDA 087851—Feb 09, 1983
METHYLPREDNISOLONE SODIUM SUCCINATEWATSON LABSANDA 086953—Jul 22, 1982
METHYLPREDNISOLONE SODIUM SUCCINATEWATSON LABSANDA 087030—Jul 22, 1982
METHYLPREDNISOLONE×2ORGANON USA INCANDA 087535—Jun 25, 1982
A-METHAPREDHOSPIRAANDA 085852—Approved Prior to Jan 1, 1982
A-METHAPREDHOSPIRAANDA 085853—Approved Prior to Jan 1, 1982
A-METHAPREDHOSPIRAANDA 085855—Approved Prior to Jan 1, 1982
A-METHAPREDHOSPIRAANDA 085854—Approved Prior to Jan 1, 1982
METHYLPREDNISOLONE×4ELKINS SINNANDA 086906—Approved Prior to Jan 1, 1982

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.

Methylprednisolone sodium succinate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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