FDA.reportPublic FDA data

Application 081268

Type
ANDA
Sponsor
TEVA PARENTERAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEINJECTABLE;INJECTIONEQ 1GM BASE/VIALNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A081268-001METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEEQ 1GM BASE/VIALINJECTABLE / INJECTION1992-11-30

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A081268-001METHYLPREDNISOLONE SODIUM SUCCINATEEQ 1GM BASE/VIALINJECTABLE / INJECTION1992-11-30a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEHF Acquisition Co LLC, DBA HealthFirst559427ac-9fc6-96f5-e063-6294a90a0b302026-07-24Warnings, Adverse reactionsName fallback
brand name: METHYLPREDNISOLONE SODIUM SUCCINATE
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
SOLU-MEDROLMETHYLPREDNISOLONE SODIUM SUCCINATESportpharm LLC0cb0ba76-067f-46c4-a5d8-b585d5ecafe32026-07-23Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Solu-MedrolMETHYLPREDNISOLONE SODIUM SUCCINATECardinal Health 107, LLC68ef8ec4-16de-4a8c-8696-b093596603802026-07-17Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
SOLU-MEDROLMETHYLPREDNISOLONE SODIUM SUCCINATEPharmacia & Upjohn Company LLC7271310c-7764-4812-aa30-a5e90987c7a92026-06-25Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONE SODIUM SUCCINATEEugia US LLC2035f00e-2299-473a-b004-cb93f541cfa92026-06-12Warnings, Adverse reactionsName fallback
brand name: Methylprednisolone Sodium Succinate
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Solu-MedrolMETHYLPREDNISOLONE SODIUM SUCCINATEHenry Schein, Inc.ea2f9b6f-2375-40a6-8b97-b607b9f3ac632026-06-04Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
SOLU-MEDROLMETHYLPREDNISOLONE SODIUM SUCCINATEA-S Medication Solutions8e5997ed-f4a5-43f7-abbd-c8e2219fe0e92026-05-29Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Solu-MedrolMETHYLPREDNISOLONE SODIUM SUCCINATECardinal Health 107, LLC2af28649-2553-4bcc-9cb1-c73f7cec76d52026-05-20Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Methylprednisolone sodium succinateMETHYLPREDNISOLONE SODIUM SUCCINATEREMEDYREPACK INC.f339882f-c380-4022-bdcd-94556a7926aa2026-04-15Warnings, Adverse reactionsName fallback
brand name: Methylprednisolone sodium succinate
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Solu-MedrolMETHYLPREDNISOLONE SODIUM SUCCINATEHenry Schein, Inc.decceb81-e922-4b72-a278-3ed80f4adb042026-03-18Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONE SODIUM SUCCINATEHikma Pharmaceuticals USA Inc.060bcf13-ce9e-488c-ad43-9d66abb23b182026-02-17Warnings, Adverse reactionsName fallback
brand name: Methylprednisolone Sodium Succinate
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONE SODIUM SUCCINATECivica, Inc.2e6020f5-a486-41cc-8956-58b5f6751aa22026-02-17Warnings, Adverse reactionsName fallback
brand name: Methylprednisolone Sodium Succinate
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONE SODIUM SUCCINATEHikma Pharmaceuticals USA Inc.05d95a56-b03a-4d5b-9877-2853ac470fa12026-02-13Warnings, Adverse reactionsName fallback
brand name: Methylprednisolone Sodium Succinate
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONE SODIUM SUCCINATEHikma Pharmaceuticals USA Inc.2e540674-0915-4498-8e2b-751c7e97532a2026-02-13Warnings, Adverse reactionsName fallback
brand name: Methylprednisolone Sodium Succinate
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
SOLU-MEDROLMETHYLPREDNISOLONE SODIUM SUCCINATEREMEDYREPACK INC.1d5ef347-2e9a-432f-9a88-a7c4ba3002672026-01-30Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Solu-MedrolMETHYLPREDNISOLONE SODIUM SUCCINATECardinal Health 107, LLC7e38b09c-da41-4ee3-8f99-812d3276d5512025-12-19Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
SOLU-MEDROLMETHYLPREDNISOLONE SODIUM SUCCINATEProPharma Distribution42df21df-9284-4505-e063-6294a90a70242025-12-18Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONETianjin Kingyork Pharmaceuticals Co., Ltd77a8d96c-37df-4f3a-9757-b2d4131ff82b2025-12-18Warnings, Adverse reactionsName fallback
brand name: Methylprednisolone Sodium Succinate
Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONEAmneal Pharmaceuticals LLCe86fbda8-00e4-4d54-841a-59dea6c15e702025-12-15Warnings, Adverse reactionsName fallback
brand name: Methylprednisolone Sodium Succinate
SOLU-MEDROLMETHYLPREDNISOLONE SODIUM SUCCINATEPharmacia & Upjohn Company LLCcd99be87-c8d9-48d6-a8e5-e081052e3f192025-12-02Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE