FDA.reportPublic FDA data

Application 218201

Type
NDA
Sponsor
SEBELA WOMENS HLTH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MIUDELLACOPPERSYSTEM;INTRAUTERINEN/AYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 45.

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
N218201-001MIUDELLACOPPERN/ASYSTEM / INTRAUTERINERLD, RS2025-02-24

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N218201-001101595962032-08-14Drug product2025-03-19
N218201-001101885462032-08-14Drug product2025-03-19
N218201-001118501812032-08-14Drug product2025-03-19
N218201-00194273512032-08-14Drug product2025-03-19
N218201-00190894182033-04-09Drug product2025-03-19
N218201-001121381992033-10-18Drug product2025-03-19
N218201-001103985882034-02-24U-4155Drug product2025-03-19
N218201-00196101912034-02-24U-41552025-03-19
N218201-001100222642034-03-22Drug product2025-03-19
N218201-00191800402034-03-22Drug product2026-04-23
N218201-00192656522034-04-28U-41552025-03-19
N218201-001101661412034-06-13Drug product2025-03-19
N218201-001112072092034-08-16Drug product2025-03-19
N218201-001109185162037-01-23Drug product2025-03-19

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N218201-001NP2028-02-24

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
2026-11-14 07:37:172026-10N218201-001MIUDELLAN/ASYSTEM / INTRAUTERINERLD, RS2025-02-24d4dbc9d85df4…
2026-10-15 13:18:302026-09N218201-001MIUDELLAN/ASYSTEM / INTRAUTERINERLD, RS2025-02-24c2088c7a36db…
2026-09-14 22:38:342026-08N218201-001MIUDELLAN/ASYSTEM / INTRAUTERINERLD, RS2025-02-2484e616aacf4f…
2026-08-18 06:07:402026-07N218201-001MIUDELLAN/ASYSTEM / INTRAUTERINERLD, RS2025-02-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218201-001MIUDELLAN/ASYSTEM / INTRAUTERINERLD, RS2025-02-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218201-001MIUDELLAN/ASYSTEM / INTRAUTERINERLD, RS2025-02-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N218201-001MIUDELLAN/ASYSTEM / INTRAUTERINERLD, RS2025-02-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218201-001MIUDELLAN/ASYSTEM / INTRAUTERINERLD, RS2025-02-24fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218201-001MIUDELLAN/ASYSTEM / INTRAUTERINERLD, RS2025-02-24a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 3 · 109 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-11-14 07:37:172026-10N218201-001101595962032-08-14Drug product2025-03-19d4dbc9d85df4…
2026-11-14 07:37:172026-10N218201-001101885462032-08-14Drug product2025-03-19d4dbc9d85df4…
2026-11-14 07:37:172026-10N218201-001118501812032-08-14Drug product2025-03-19d4dbc9d85df4…
2026-11-14 07:37:172026-10N218201-00194273512032-08-14Drug product2025-03-19d4dbc9d85df4…
2026-11-14 07:37:172026-10N218201-00190894182033-04-09Drug product2025-03-19d4dbc9d85df4…
2026-11-14 07:37:172026-10N218201-001121381992033-10-18Drug product2025-03-19d4dbc9d85df4…
2026-11-14 07:37:172026-10N218201-001103985882034-02-24U-4155Drug product2025-03-19d4dbc9d85df4…
2026-11-14 07:37:172026-10N218201-00196101912034-02-24U-41552025-03-19d4dbc9d85df4…
2026-11-14 07:37:172026-10N218201-001100222642034-03-22Drug product2025-03-19d4dbc9d85df4…
2026-11-14 07:37:172026-10N218201-00191800402034-03-22Drug product2026-04-23d4dbc9d85df4…
2026-11-14 07:37:172026-10N218201-00192656522034-04-28U-41552025-03-19d4dbc9d85df4…
2026-11-14 07:37:172026-10N218201-001101661412034-06-13Drug product2025-03-19d4dbc9d85df4…
2026-11-14 07:37:172026-10N218201-001112072092034-08-16Drug product2025-03-19d4dbc9d85df4…
2026-11-14 07:37:172026-10N218201-001109185162037-01-23Drug product2025-03-19d4dbc9d85df4…
2026-10-15 13:18:302026-09N218201-001101595962032-08-14Drug product2025-03-19c2088c7a36db…
2026-10-15 13:18:302026-09N218201-001101885462032-08-14Drug product2025-03-19c2088c7a36db…
2026-10-15 13:18:302026-09N218201-001118501812032-08-14Drug product2025-03-19c2088c7a36db…
2026-10-15 13:18:302026-09N218201-00194273512032-08-14Drug product2025-03-19c2088c7a36db…
2026-10-15 13:18:302026-09N218201-00190894182033-04-09Drug product2025-03-19c2088c7a36db…
2026-10-15 13:18:302026-09N218201-001121381992033-10-18Drug product2025-03-19c2088c7a36db…
2026-10-15 13:18:302026-09N218201-001103985882034-02-24U-4155Drug product2025-03-19c2088c7a36db…
2026-10-15 13:18:302026-09N218201-00196101912034-02-24U-41552025-03-19c2088c7a36db…
2026-10-15 13:18:302026-09N218201-001100222642034-03-22Drug product2025-03-19c2088c7a36db…
2026-10-15 13:18:302026-09N218201-00191800402034-03-22Drug product2026-04-23c2088c7a36db…
2026-10-15 13:18:302026-09N218201-00192656522034-04-28U-41552025-03-19c2088c7a36db…
2026-10-15 13:18:302026-09N218201-001101661412034-06-13Drug product2025-03-19c2088c7a36db…
2026-10-15 13:18:302026-09N218201-001112072092034-08-16Drug product2025-03-19c2088c7a36db…
2026-10-15 13:18:302026-09N218201-001109185162037-01-23Drug product2025-03-19c2088c7a36db…
2026-09-14 22:38:342026-08N218201-001101595962032-08-14Drug product2025-03-1984e616aacf4f…
2026-09-14 22:38:342026-08N218201-001101885462032-08-14Drug product2025-03-1984e616aacf4f…
2026-09-14 22:38:342026-08N218201-001118501812032-08-14Drug product2025-03-1984e616aacf4f…
2026-09-14 22:38:342026-08N218201-00194273512032-08-14Drug product2025-03-1984e616aacf4f…
2026-09-14 22:38:342026-08N218201-00190894182033-04-09Drug product2025-03-1984e616aacf4f…
2026-09-14 22:38:342026-08N218201-001121381992033-10-18Drug product2025-03-1984e616aacf4f…
2026-09-14 22:38:342026-08N218201-001103985882034-02-24U-4155Drug product2025-03-1984e616aacf4f…
2026-09-14 22:38:342026-08N218201-00196101912034-02-24U-41552025-03-1984e616aacf4f…
2026-09-14 22:38:342026-08N218201-001100222642034-03-22Drug product2025-03-1984e616aacf4f…
2026-09-14 22:38:342026-08N218201-00191800402034-03-22Drug product2026-04-2384e616aacf4f…
2026-09-14 22:38:342026-08N218201-00192656522034-04-28U-41552025-03-1984e616aacf4f…
2026-09-14 22:38:342026-08N218201-001101661412034-06-13Drug product2025-03-1984e616aacf4f…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-11-14 07:37:172026-10N218201-001NP2028-02-24d4dbc9d85df4…
2026-10-15 13:18:302026-09N218201-001NP2028-02-24c2088c7a36db…
2026-09-14 22:38:342026-08N218201-001NP2028-02-2484e616aacf4f…
2026-08-18 06:07:402026-07N218201-001NP2028-02-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218201-001NP2028-02-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218201-001NP2028-02-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N218201-001NP2028-02-246a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218201-001NP2028-02-24a50c72e98297…

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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83637SUPPL 2025-10-03
83636SUPPL 2025-10-03
83635SUPPL 2025-10-03
81368ORIG 2025-02-25
81343ORIG 2025-02-25