Home Applications 218201 Application 218201
Type NDA
Sponsor SEBELA WOMENS HLTH Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MIUDELLA COPPER SYSTEM;INTRAUTERINE N/A Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N218201-001 MIUDELLA COPPER N/A SYSTEM / INTRAUTERINE RLD, RS 2025-02-24
Orange Book patents# Current patent rows page 1 of 1 · 14 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N218201-001 10159596 2032-08-14 Drug product 2025-03-19 N218201-001 10188546 2032-08-14 Drug product 2025-03-19 N218201-001 11850181 2032-08-14 Drug product 2025-03-19 N218201-001 9427351 2032-08-14 Drug product 2025-03-19 N218201-001 9089418 2033-04-09 Drug product 2025-03-19 N218201-001 12138199 2033-10-18 Drug product 2025-03-19 N218201-001 10398588 2034-02-24 U-4155 Drug product 2025-03-19 N218201-001 9610191 2034-02-24 U-4155 2025-03-19 N218201-001 10022264 2034-03-22 Drug product 2025-03-19 N218201-001 9180040 2034-03-22 Drug product 2026-04-23 N218201-001 9265652 2034-04-28 U-4155 2025-03-19 N218201-001 10166141 2034-06-13 Drug product 2025-03-19 N218201-001 11207209 2034-08-16 Drug product 2025-03-19 N218201-001 10918516 2037-01-23 Drug product 2025-03-19
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N218201-001 NP 2028-02-24
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N218201-001 MIUDELLA N/A SYSTEM / INTRAUTERINE RLD, RS 2025-02-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218201-001 MIUDELLA N/A SYSTEM / INTRAUTERINE RLD, RS 2025-02-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218201-001 MIUDELLA N/A SYSTEM / INTRAUTERINE RLD, RS 2025-02-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218201-001 MIUDELLA N/A SYSTEM / INTRAUTERINE RLD, RS 2025-02-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218201-001 MIUDELLA N/A SYSTEM / INTRAUTERINE RLD, RS 2025-02-24 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218201-001 MIUDELLA N/A SYSTEM / INTRAUTERINE RLD, RS 2025-02-24 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 67 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N218201-001 10159596 2032-08-14 Drug product 2025-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218201-001 10188546 2032-08-14 Drug product 2025-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218201-001 11850181 2032-08-14 Drug product 2025-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218201-001 9427351 2032-08-14 Drug product 2025-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218201-001 9089418 2033-04-09 Drug product 2025-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218201-001 12138199 2033-10-18 Drug product 2025-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218201-001 10398588 2034-02-24 U-4155 Drug product 2025-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218201-001 9610191 2034-02-24 U-4155 2025-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218201-001 10022264 2034-03-22 Drug product 2025-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218201-001 9180040 2034-03-22 Drug product 2026-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218201-001 9265652 2034-04-28 U-4155 2025-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218201-001 10166141 2034-06-13 Drug product 2025-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218201-001 11207209 2034-08-16 Drug product 2025-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218201-001 10918516 2037-01-23 Drug product 2025-03-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218201-001 10159596 2032-08-14 Drug product 2025-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218201-001 10188546 2032-08-14 Drug product 2025-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218201-001 11850181 2032-08-14 Drug product 2025-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218201-001 9427351 2032-08-14 Drug product 2025-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218201-001 9089418 2033-04-09 Drug product 2025-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218201-001 12138199 2033-10-18 Drug product 2025-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218201-001 10398588 2034-02-24 U-4155 Drug product 2025-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218201-001 9610191 2034-02-24 U-4155 2025-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218201-001 10022264 2034-03-22 Drug product 2025-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218201-001 9265652 2034-04-28 U-4155 2025-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218201-001 10166141 2034-06-13 Drug product 2025-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218201-001 11207209 2034-08-16 Drug product 2025-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218201-001 10918516 2037-01-23 Drug product 2025-03-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218201-001 10159596 2032-08-14 Drug product 2025-03-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218201-001 10188546 2032-08-14 Drug product 2025-03-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218201-001 11850181 2032-08-14 Drug product 2025-03-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218201-001 9427351 2032-08-14 Drug product 2025-03-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218201-001 9089418 2033-04-09 Drug product 2025-03-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218201-001 12138199 2033-10-18 Drug product 2025-03-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218201-001 10398588 2034-02-24 U-4155 Drug product 2025-03-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218201-001 9610191 2034-02-24 U-4155 2025-03-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218201-001 10022264 2034-03-22 Drug product 2025-03-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218201-001 9265652 2034-04-28 U-4155 2025-03-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218201-001 10166141 2034-06-13 Drug product 2025-03-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218201-001 11207209 2034-08-16 Drug product 2025-03-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218201-001 10918516 2037-01-23 Drug product 2025-03-19 31067a03dcf5…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-18 06:07:40 2026-07 N218201-001 NP 2028-02-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218201-001 NP 2028-02-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218201-001 NP 2028-02-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218201-001 NP 2028-02-24 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218201-001 NP 2028-02-24 a50c72e98297…
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Miudella COPPER Organon LLC 4a75ebac-a765-460d-bb6a-9fbabb0b927d 2026-07-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 218201 application number: NDA218201
Documents# Document, Submission type, Date table Document Submission type Date 83637 SUPPL 2025-10-03 83636 SUPPL 2025-10-03 83635 SUPPL 2025-10-03 81368 ORIG 2025-02-25 81343 ORIG 2025-02-25