FDA.reportPublic FDA data

Application 008085

Type
NDA
Sponsor
DAVA PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002METHOTREXATE SODIUMMETHOTREXATE SODIUMTABLET;ORALEQ 2.5MG BASEYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N008085-002METHOTREXATE SODIUMMETHOTREXATE SODIUMEQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N008085-002METHOTREXATE SODIUMEQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N008085-002METHOTREXATE SODIUMEQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N008085-002METHOTREXATE SODIUMEQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N008085-002METHOTREXATE SODIUMEQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N008085-002AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12N008085-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N008085-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N008085-002AB1ea99ee380514…

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
brand name: Methotrexate Sodium
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
brand name: Methotrexate Sodium
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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42254-110METHOTREXATEMETHOTREXATERebel Distributors CorpNDACurrent
50090-0294METHOTREXATEMETHOTREXATEA-S Medication SolutionsNDACurrent
50090-0294METHOTREXATEMETHOTREXATEA-S Medication SolutionsNDACurrent
66336-338METHOTREXATEMETHOTREXATEDispensing Solutions, Inc.NDACurrent
67253-320METHOTREXATEMETHOTREXATEPar PharmaceuticalNDACurrent
67253-320METHOTREXATEMETHOTREXATEPar Pharmaceutical, Inc.NDACurrent
70518-0223METHOTREXATEMETHOTREXATEREMEDYREPACK INC.NDACurrent
70518-0223METHOTREXATEMETHOTREXATEREMEDYREPACK INC.NDACurrent
70518-0223METHOTREXATEMETHOTREXATEREMEDYREPACK INC.NDACurrent
75840-111METHOTREXATE SODIUMMETHOTREXATE SODIUMGenPak Solutions LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62824SUPPL2020-05-05
62817SUPPL2020-05-05
53061SUPPL2018-03-20
53042SUPPL2018-03-16
32958SUPPL2016-02-18
142SUPPL2016-02-01
141SUPPL2006-06-02
32957SUPPL2003-11-05
32956SUPPL2003-11-05
91SUPPL2003-11-05
89SUPPL2003-11-05
140SUPPL2002-02-20
90SUPPL2002-02-20