FDA.reportPublic FDA data

Application 074002

Type
ANDA
Sponsor
FOSUN PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOLMETIN SODIUMTOLMETIN SODIUMTABLET;ORALEQ 600MG BASENoNo

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
A074002-001TOLMETIN SODIUMTOLMETIN SODIUMEQ 600MG BASETABLET / ORAL1993-09-27

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 UTC2022-09A074002-001TOLMETIN SODIUMEQ 600MG BASETABLET / ORAL1993-09-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074002-001TOLMETIN SODIUMEQ 600MG BASETABLET / ORAL1993-09-27cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A074002-001TOLMETIN SODIUMEQ 600MG BASETABLET / ORAL1993-09-27a50c72e98297…

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
Tolmetin SodiumTOLMETIN SODIUMChartwell RX, LLC66fa5e73-477c-4bbc-b7d3-f4a69aad44602026-07-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tolmetin Sodium
generic name: TOLMETIN SODIUM
Tolmetin SodiumTOLMETIN SODIUMLifsa Drugs LLC7b26321c-4797-4664-a162-e29de4b8dd932026-05-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tolmetin Sodium
generic name: TOLMETIN SODIUM
TOLMETIN SODIUMTOLMETIN SODIUMGalt Pharmaceuticals, LLC0a97800f-706d-4787-98fe-08dadf9c4d5f2026-03-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TOLMETIN SODIUM
generic name: TOLMETIN SODIUM
TolectinTOLMETIN SODIUMPoly Pharmaceuticals, Inc.15467b19-e43a-5be9-e063-6294a90a3cca2025-12-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: TOLMETIN SODIUM
Tolmetin SodiumTOLMETIN SODIUMAtland Pharmaceuticals, LLCe6150446-c5ef-4437-b488-067876649fcc2025-03-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tolmetin Sodium
generic name: TOLMETIN SODIUM
Tolmetin SodiumTOLMETIN SODIUMAtland Pharmaceuticals, LLC41b7704e-25a1-45e8-93c0-9ac2f0effef92025-03-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tolmetin Sodium
generic name: TOLMETIN SODIUM

Reported adverse events (FAERS/openFDA)#

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