FDA.reportPublic FDA data

Application 018205

Type
NDA
Sponsor
GD SEARLE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TATUM-TCOPPERINTRAUTERINE DEVICE;INTRAUTERINE120MGNoNo

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
N018205-001TATUM-TCOPPER120MGINTRAUTERINE DEVICE / INTRAUTERINEApproved 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 UTC2022-10N018205-001TATUM-T120MGINTRAUTERINE DEVICE / INTRAUTERINEApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018205-001TATUM-T120MGINTRAUTERINE DEVICE / INTRAUTERINEApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018205-001TATUM-T120MGINTRAUTERINE DEVICE / INTRAUTERINEApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N018205-001TATUM-T120MGINTRAUTERINE DEVICE / INTRAUTERINEApproved before 1982a50c72e98297…

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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MiudellaCOPPEROrganon LLC4a75ebac-a765-460d-bb6a-9fbabb0b927d2026-07-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: COPPER
Cuprum Metallicum 6XCOPPERTrue Botanica, LLC226a797f-bcea-7eb8-e063-6394a90a0b4d2024-12-12WarningsName fallback
generic name: COPPER
ParaGard T 380ACOPPERCooperSurgical, Inc.3c420b53-c95e-46af-aebd-73741be583912024-06-09Warnings, Adverse reactionsName fallback
generic name: COPPER
Cuprum metallicumCOPPERBoiron8579c8eb-c70d-3261-e053-2a91aa0abb392023-12-07Name fallback
generic name: COPPER
Cuprum metallicumCOPPERBoiron76f10500-7a53-11e6-a412-424c583030312023-11-13Name fallback
generic name: COPPER
Cuprum metallicumCOPPERBoiron85799c07-0bdb-20e5-e053-2a91aa0a4f0a2023-11-13Name fallback
generic name: COPPER
Cuprum metallicumCOPPERBoiron85799e57-2ab4-ffc0-e053-2991aa0a8adf2023-11-13Name fallback
generic name: COPPER
Cuprum metallicumCOPPERBoiron85791c37-f9af-6b8a-e053-2a91aa0ad0b32023-11-13Name fallback
generic name: COPPER
Cuprum metallicumCOPPERBoiron857988b5-72d4-af40-e053-2991aa0a84462023-11-13Name fallback
generic name: COPPER
Cuprum metallicumCOPPERBoiron857a5e6a-cfe6-9df4-e053-2991aa0a2c9e2023-11-13Name fallback
generic name: COPPER
Cuprum metallicumCOPPERBoiron857a6582-ba8a-4343-e053-2a91aa0ad1382023-11-13Name fallback
generic name: COPPER
Cuprum metallicumCOPPERBoiron857a1e8d-20df-44a0-e053-2991aa0abb222023-11-13Name fallback
generic name: COPPER
Cuprum metallicumCOPPERBoiron8579e35d-a278-b962-e053-2991aa0ac6f92023-01-20Name fallback
generic name: COPPER
Cuprum metallicumCOPPERBoiron85794f6b-d22d-40f9-e053-2991aa0a88232023-01-20Name fallback
generic name: COPPER
Cuprum metallicumCOPPERBoiron857a0e2a-2731-467f-e053-2991aa0a8cc62023-01-13Name fallback
generic name: COPPER
ParaGard T 380ACOPPERCooperSurgical, Inc.5ea7ce51-b87a-485e-b841-99466a07a4b22019-09-09Warnings, Adverse reactionsName fallback
generic name: COPPER

Reported adverse events (FAERS/openFDA)#

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