FDA.reportPublic FDA data

Application 089355

Type
ANDA
Sponsor
ABIC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ABITREXATEMETHOTREXATE SODIUMINJECTABLE;INJECTIONEQ 100MG BASE/VIALNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A089355-001ABITREXATEMETHOTREXATE SODIUMEQ 100MG BASE/VIALINJECTABLE / INJECTION1987-07-17

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.

Product history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A089355-001ABITREXATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1987-07-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A089355-001ABITREXATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1987-07-17cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A089355-001ABITREXATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1987-07-17a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methotrexate SodiumMETHOTREXATE SODIUMElite Laboratories, Inc.89c05ea3-3be1-46dd-b112-29c436fd72892026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHOTREXATE SODIUM
MethotrexateMETHOTREXATE SODIUMSun Pharmaceutical Industries, Inc.8f1260de-b60c-4f0e-8af6-0e957b0a281b2026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHOTREXATE SODIUM
Methotrexate SodiumMETHOTREXATE SODIUMHikma Pharmaceuticals USA Inc.d71b1856-99d8-4a9e-9189-f87b6675f80a2026-05-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHOTREXATE SODIUM
MethotrexateMETHOTREXATE SODIUMFresenius Kabi USA, LLCec476b11-0b3c-4139-b1eb-a3daa76bc2712025-08-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHOTREXATE SODIUM
MethotrexateMETHOTREXATE SODIUMBryant Ranch Prepackc7592288-ac24-46c6-8cec-9abe23d7e81e2023-12-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHOTREXATE SODIUM
MethotrexateMETHOTREXATE SODIUMFresenius Kabi USA, LLCb585f621-f6c9-4735-ab61-bd1b401f3df02021-03-24Boxed warning, Adverse reactionsName fallback
generic name: METHOTREXATE SODIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.