FDA Orange Book · active-ingredient family
Methylprednisolone
Methylprednisolone: 1 brand, 18 generics; first approved Feb 09, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 18 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
18
Listed patents
0
Presentations
37
Brand (NDA) products
Originator applications
- MEDROLRLDPFIZERNDA 011153-6 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Rx AB 2MG TABLET ORAL Rx - 16MG TABLET ORAL Rx AB 8MG TABLET ORAL Rx AB 24MG TABLET ORAL Discontinued - 32MG TABLET ORAL Rx AB
Generic (ANDA) products (18)
Abbreviated applications
- METHYLPREDNISOLONEAMNEALANDA 20748120214 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued - 8MG TABLET ORAL Discontinued - 16MG TABLET ORAL Discontinued - 32MG TABLET ORAL Discontinued - - METHYLPREDNISOLONEPRAXGENANDA 2122622019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued - - METHYLPREDNISOLONECHARTWELL RXANDA 20909720195 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Discontinued - 4MG TABLET ORAL Discontinued - 8MG TABLET ORAL Discontinued - 16MG TABLET ORAL Discontinued - 32MG TABLET ORAL Discontinued - - METHYLPREDNISOLONEINGENUS PHARMS LLCANDA 2109852019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued - - METHYLPREDNISOLONETIANJIN TIANYAOANDA 2040722018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Rx AB - METHYLPREDNISOLONEZYDUS PHARMSANDA 20675120184 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Rx AB 8MG TABLET ORAL Rx AB 16MG TABLET ORAL Rx AB 32MG TABLET ORAL Rx AB - METHYLPREDNISOLONEPH HEALTHANDA 0401831998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Rx AB - METHYLPREDNISOLONEJUBILANT CADISTAANDA 04018919974 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Rx AB 8MG TABLET ORAL Rx AB 16MG TABLET ORAL Rx AB 32MG TABLET ORAL Rx AB - METHYLPREDNISOLONESANDOZANDA 0401941997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Rx AB - METHYLPREDNISOLONEWATSON LABSANDA 0402321997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Rx AB - METHYLPREDNISOLONEPAR PHARMANDA 0892071988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 16MG TABLET ORAL Discontinued - - METHYLPREDNISOLONEPAR PHARMANDA 0892081988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 24MG TABLET ORAL Discontinued - - METHYLPREDNISOLONEPAR PHARMANDA 0892091988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 32MG TABLET ORAL Discontinued - - METHYLPREDNISOLONEDURAMED PHARMS BARRANDA 0884971984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued - - METHYLPREDNISOLONEWATSON LABSANDA 0861611982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued - - METHYLPREDNISOLONEWATSON LABSANDA 0861591982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 16MG TABLET ORAL Discontinued - - METHYLPREDNISOLONEHEATHERANDA 085650-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL Discontinued - - METHYLPREDNISOLONERISINGANDA 087341-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4MG TABLET ORAL 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
45 yr 4 mo ago
Most recent approval
5 yr 2 mo ago
Approvals span 1982–2021 across 19 FDA applications.
Brand (NDA) 15%
Generic (ANDA) 1895%
Methylprednisolone: 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.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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