FDA.reportPublic FDA data

Application 074819

Type
ANDA
Sponsor
OXFORD PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ETODOLACETODOLACTABLET;ORAL400MGNoNo
002ETODOLACETODOLACTABLET;ORAL500MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074819-001ETODOLACETODOLAC400MGTABLET / ORAL1997-02-28
A074819-002ETODOLACETODOLAC500MGTABLET / ORAL1998-04-28

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 22:54:322026-06A074819-001ETODOLAC400MGTABLET / ORAL1997-02-28a50c72e98297…
2026-08-01 22:54:322026-06A074819-002ETODOLAC500MGTABLET / ORAL1998-04-28a50c72e98297…

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 4 · 74 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EtodolacETODOLACAurobindo Pharma Limitedc74c3c56-a5ac-40b4-974b-c4f4b05c5df92026-07-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Etodolac
generic name: ETODOLAC
EtodolacETODOLACSun Pharmaceutical Industries, Inc.ec82b108-6a6f-4d1b-82cb-831d4ed36c802026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Etodolac
generic name: ETODOLAC
EtodolacETODOLACTaSun Pharmaceutical Industries, Inc.2c5b44b4-78d5-43b2-827d-d2763b6672b32026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Etodolac
generic name: ETODOLAC
EtodolacETODOLACSt. Marys Medical Park Pharmacy60cb4de0-ed88-a46b-e053-2a91aa0a8b6d2026-06-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Etodolac
generic name: ETODOLAC
EtodolacETODOLACREMEDYREPACK INC.cad9b5ca-a9d4-41d4-aff2-67d0c458aad62026-06-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Etodolac
generic name: ETODOLAC
EtodolacETODOLACPD-Rx Pharmaceuticals, Inc.007c55fa-ef8b-4a8e-bfe5-e47c6e5da7272026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Etodolac
generic name: ETODOLAC
EtodolacETODOLACSt. Mary's Medical Park Pharmacy6761e6b1-2399-4643-e053-2991aa0a6f172026-05-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Etodolac
generic name: ETODOLAC
EtodolacETODOLACPD-Rx Pharmaceuticals, Inc.41bd86b9-2ef3-49a4-874e-fe8ac68910802026-05-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Etodolac
generic name: ETODOLAC
EtodolacETODOLACPD-Rx Pharmaceuticals, Inc.556eaa67-d30d-4095-a981-c65f98d3acdd2026-04-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Etodolac
generic name: ETODOLAC
EtodolacETODOLACPreferred Pharmaceuticals Inc.117b3005-a8ec-4f76-824c-95ec42dc87a12026-04-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Etodolac
generic name: ETODOLAC
EtodolacETODOLACPreferred Pharmaceuticals Inc.55ae2e78-d803-496b-b66d-af11403127852026-04-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Etodolac
generic name: ETODOLAC
EtodolacETODOLACBryant Ranch Prepackea12933b-2280-4a11-a0e3-554194c53c4d2026-03-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Etodolac
generic name: ETODOLAC
EtodolacETODOLACBryant Ranch Prepack301087e4-f05c-4fd3-8815-c86c6f12ff612026-03-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Etodolac
generic name: ETODOLAC
EtodolacETODOLACBryant Ranch Prepacka355160d-24c3-4a4d-99ea-84c80ce67f902026-03-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Etodolac
generic name: ETODOLAC
EtodolacETODOLACBryant Ranch Prepacke7a81661-28a2-40d7-8c90-786629c81e362026-03-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Etodolac
generic name: ETODOLAC
EtodolacETODOLACBryant Ranch Prepack03458123-e27c-4447-9ef3-3bd32481cb972026-03-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Etodolac
generic name: ETODOLAC
etodolacETODOLACIpca Laboratories Limitedf50a93ca-584a-4205-a79b-31bafdd309c22026-01-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: etodolac
generic name: ETODOLAC
etodolacETODOLACIpca Laboratories Limitedd583988c-3e7e-4415-b2fd-34049791cd1c2026-01-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: etodolac
generic name: ETODOLAC
EtodolacETODOLACA-S Medication Solutions336d5331-4d60-42e2-8cfc-aad57c01eda02026-01-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Etodolac
generic name: ETODOLAC
EtodolacETODOLACA-S Medication Solutions00125d63-d8d0-46c5-bdf1-80d2c85eda5a2026-01-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Etodolac
generic name: ETODOLAC

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67296-0595ETODOLACetodolacRedPharm Drug Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
53916ORIG2018-05-01