FDA.reportPublic FDA data

Application 203407

Type
ANDA
Sponsor
SAGENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHOTREXATE SODIUM PRESERVATIVE FREEMETHOTREXATE SODIUMINJECTABLE;INJECTIONEQ 50MG BASE/2ML (EQ 25MG BASE/ML)NoNo
002METHOTREXATE SODIUM PRESERVATIVE FREEMETHOTREXATE SODIUMINJECTABLE;INJECTIONEQ 250MG BASE/10ML (EQ 25MG BASE/ML)NoNo
003METHOTREXATE SODIUM PRESERVATIVE FREEMETHOTREXATE SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/40ML (EQ 25MG BASE/ML)NoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203407-001METHOTREXATE SODIUM PRESERVATIVE FREEMETHOTREXATE SODIUMEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2018-08-09
A203407-002METHOTREXATE SODIUM PRESERVATIVE FREEMETHOTREXATE SODIUMEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2018-08-09
A203407-003METHOTREXATE SODIUM PRESERVATIVE FREEMETHOTREXATE SODIUMEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2018-08-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A203407-001AP
A203407-002AP
A203407-003AP

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 22:54:322026-06A203407-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2018-08-09a50c72e98297…
2026-08-01 22:54:322026-06A203407-002METHOTREXATE SODIUM PRESERVATIVE FREEEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2018-08-09a50c72e98297…
2026-08-01 22:54:322026-06A203407-003METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2018-08-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A203407-001AP1a50c72e98297…
2026-08-01 22:54:322026-06A203407-002AP1a50c72e98297…
2026-08-01 22:54:322026-06A203407-003AP1a50c72e98297…

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 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