FDA Orange Book · active-ingredient family
Methylprednisolone sodium succinate
Methylprednisolone sodium succinate: 1 brand, 48 generics; first approved Jun 25, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 48 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
48
Listed patents
0
Presentations
75
Brand (NDA) products
Originator applications
- PHARMACIA AND UPJOHNNDA 011856—5 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 125MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 2GM BASE/VIAL INJECTABLE INJECTION Rx AP
Generic (ANDA) products (48)
Abbreviated applications
- METHYLPREDNISOLONE SODIUM SUCCINATEHIKMAANDA 20312520222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 125MG BASE/VIAL INJECTABLE INJECTION Rx AP - METHYLPREDNISOLONE SODIUM SUCCINATETIANJIN KINGYORKANDA 21239620215 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 125MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 2GM BASE/VIAL INJECTABLE INJECTION Rx AP - METHYLPREDNISOLONE SODIUM SUCCINATEAMNEALANDA 20754920162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 125MG BASE/VIAL INJECTABLE INJECTION Rx AP - METHYLPREDNISOLONE SODIUM SUCCINATEHIKMAANDA 20269120162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP - METHYLPREDNISOLONE SODIUM SUCCINATEEUGIA PHARMAANDA 20766720154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 125MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 2GM BASE/VIAL INJECTABLE INJECTION Discontinued — - METHYLPREDNISOLONE SODIUM SUCCINATESAGENT PHARMS INCANDA 04088820115 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 125MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 2GM BASE/VIAL INJECTABLE INJECTION Rx AP - HOSPIRA INCANDA 0407932008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INJECTION Discontinued — - HOSPIRA INCANDA 0408272008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/VIAL INJECTABLE INJECTION Discontinued — - METHYLPREDNISOLONE SODIUM SUCCINATEBEDFORD LABSANDA 04064120073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - METHYLPREDNISOLONE SODIUM SUCCINATEBEDFORD LABSANDA 04070920072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - METHYLPREDNISOLONE SODIUM SUCCINATEBEDFORD LABSANDA 0406622007
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INJECTION Discontinued — - HOSPIRAANDA 0406642005
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INJECTION Discontinued — - HOSPIRAANDA 0406652005
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/VIAL INJECTABLE INJECTION Discontinued — - METHYLPREDNISOLONE SODIUM SUCCINATEFRESENIUS KABI USAANDA 0406122004
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP - METHYLPREDNISOLONE SODIUM SUCCINATEFRESENIUS KABI USAANDA 04058320042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 125MG BASE/VIAL INJECTABLE INJECTION Rx AP - METHYLPREDNISOLONE SODIUM SUCCINATETEVA PARENTERALANDA 0812681992
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - METHYLPREDNISOLONE SODIUM SUCCINATETEVA PARENTERALANDA 0812661992
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/VIAL INJECTABLE INJECTION Discontinued — - METHYLPREDNISOLONE SODIUM SUCCINATETEVA PARENTERALANDA 0812671992
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — - ABBOTTANDA 0895761991
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - ABBOTTANDA 0895731991
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INJECTION Discontinued — - ABBOTTANDA 0895741991
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/VIAL INJECTABLE INJECTION Discontinued — - ABBOTTANDA 0895751991
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — - HOSPIRAANDA 0891741987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - HOSPIRAANDA 0891731987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — - METHYLPREDNISOLONE SODIUM SUCCINATEABRAXIS PHARMANDA 0891881986
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - METHYLPREDNISOLONE SODIUM SUCCINATEABRAXIS PHARMANDA 0891891986
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - METHYLPREDNISOLONE SODIUM SUCCINATEABRAXIS PHARMANDA 0891431986
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INJECTION Discontinued — - METHYLPREDNISOLONE SODIUM SUCCINATEABRAXIS PHARMANDA 0891441986
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/VIAL INJECTABLE INJECTION Discontinued — - METHYLPREDNISOLONE SODIUM SUCCINATEABRAXIS PHARMANDA 0891861986
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — - METHYLPREDNISOLONE SODIUM SUCCINATEABRAXIS PHARMANDA 0891871986
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — - METHYLPREDNISOLONE SODIUM SUCCINATEWATSON LABSANDA 0885241984
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - METHYLPREDNISOLONE SODIUM SUCCINATEWATSON LABSANDA 0885231984
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — - METHYLPREDNISOLONE SODIUM SUCCINATEABRAXIS PHARMANDA 0886791984
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - METHYLPREDNISOLONE SODIUM SUCCINATEABRAXIS PHARMANDA 0886761984
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INJECTION Discontinued — - METHYLPREDNISOLONE SODIUM SUCCINATEABRAXIS PHARMANDA 0886771984
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/VIAL INJECTABLE INJECTION Discontinued — - METHYLPREDNISOLONE SODIUM SUCCINATEABRAXIS PHARMANDA 0886781984
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — - METHYLPREDNISOLONE SODIUM SUCCINATEINTL MEDICATIONANDA 0878521983
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - METHYLPREDNISOLONE SODIUM SUCCINATEINTL MEDICATIONANDA 0878121983
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INJECTION Discontinued — - METHYLPREDNISOLONE SODIUM SUCCINATEINTL MEDICATIONANDA 0878131983
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/VIAL INJECTABLE INJECTION Discontinued — - METHYLPREDNISOLONE SODIUM SUCCINATEINTL MEDICATIONANDA 0878511983
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — - METHYLPREDNISOLONE SODIUM SUCCINATEWATSON LABSANDA 0869531982
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INJECTION Discontinued — - METHYLPREDNISOLONE SODIUM SUCCINATEWATSON LABSANDA 0870301982
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/VIAL INJECTABLE INJECTION Discontinued — - ORGANON USA INCANDA 08753519822 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - HOSPIRAANDA 085852—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - HOSPIRAANDA 085853—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INJECTION Discontinued — - HOSPIRAANDA 085855—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE/VIAL INJECTABLE INJECTION Discontinued — - HOSPIRAANDA 085854—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — - ELKINS SINNANDA 086906—4 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 125MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued —
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
44 yr 11 mo ago
Most recent approval
4 yr 1 mo ago
Approvals span 1982–2022 across 49 FDA applications.
Brand (NDA) 12%
Generic (ANDA) 4898%
Methylprednisolone sodium succinate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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