Home Applications 206229 Application 206229
Type NDA
Sponsor MEDICINES360 Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LILETTA LEVONORGESTREL INTRAUTERINE DEVICE;INTRAUTERINE 52MG No No
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 N206229-001 LILETTA LEVONORGESTREL 52MG SYSTEM / INTRAUTERINE RLD, RS 2015-02-26
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N206229-001 12004992 2033-10-06 Drug substance 2024-07-03 N206229-001 11090186 2033-10-24 U-2348 2021-09-13 N206229-001 10028858 2034-03-22 U-2348 Drug product 2018-08-10 N206229-001 11571328 2040-09-07 Drug product 2023-02-27
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N206229-001 I-917 2026-06-29
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 1 of 2 · 42 observed 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 N206229-001 LILETTA 52MG SYSTEM / INTRAUTERINE RLD, RS 2015-02-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206229-001 LILETTA 52MG SYSTEM / INTRAUTERINE RLD, RS 2015-02-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206229-001 LILETTA 52MG SYSTEM / INTRAUTERINE RLD, RS 2015-02-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206229-001 LILETTA 52MG SYSTEM / INTRAUTERINE RLD, RS 2015-02-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206229-001 LILETTA 52MG SYSTEM / INTRAUTERINE RLD, RS 2015-02-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206229-001 LILETTA 52MG SYSTEM / INTRAUTERINE RLD, RS 2015-02-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206229-001 LILETTA 52MG SYSTEM / INTRAUTERINE RLD, RS 2015-02-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206229-001 LILETTA 52MG SYSTEM / INTRAUTERINE RLD, RS 2015-02-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206229-001 LILETTA 52MG SYSTEM / INTRAUTERINE RLD, RS 2015-02-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206229-001 LILETTA 52MG SYSTEM / INTRAUTERINE RLD, RS 2015-02-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206229-001 LILETTA 52MG SYSTEM / INTRAUTERINE RLD, RS 2015-02-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206229-001 LILETTA 52MG SYSTEM / INTRAUTERINE RLD, RS 2015-02-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206229-001 LILETTA 52MG SYSTEM / INTRAUTERINE RLD, RS 2015-02-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE 2015-02-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE 2015-02-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE 2015-02-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE 2015-02-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE 2015-02-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE 2015-02-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE 2015-02-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE 2015-02-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N206229-001 LILETTA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2015-02-26 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 3 · 114 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 N206229-001 12004992 2033-10-06 Drug substance 2024-07-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206229-001 11090186 2033-10-24 U-2348 2021-09-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206229-001 10028858 2034-03-22 U-2348 Drug product 2018-08-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206229-001 11571328 2040-09-07 Drug product 2023-02-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206229-001 12004992 2033-10-06 Drug substance 2024-07-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206229-001 11090186 2033-10-24 U-2348 2021-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206229-001 10028858 2034-03-22 U-2348 Drug product 2018-08-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206229-001 11571328 2040-09-07 Drug product 2023-02-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206229-001 12004992 2033-10-06 Drug substance 2024-07-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206229-001 11090186 2033-10-24 U-2348 2021-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206229-001 10028858 2034-03-22 U-2348 Drug product 2018-08-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206229-001 11571328 2040-09-07 Drug product 2023-02-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206229-001 12004992 2033-10-06 Drug substance 2024-07-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206229-001 11090186 2033-10-24 U-2348 2021-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206229-001 10028858 2034-03-22 U-2348 Drug product 2018-08-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206229-001 11571328 2040-09-07 Drug product 2023-02-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206229-001 12004992 2033-10-06 Drug substance 2024-07-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206229-001 11090186 2033-10-24 U-2348 2021-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206229-001 10028858 2034-03-22 U-2348 Drug product 2018-08-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206229-001 11571328 2040-09-07 Drug product 2023-02-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206229-001 12004992 2033-10-06 Drug substance 2024-07-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206229-001 11090186 2033-10-24 U-2348 2021-09-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206229-001 10028858 2034-03-22 U-2348 Drug product 2018-08-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206229-001 11571328 2040-09-07 Drug product 2023-02-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206229-001 12004992 2033-10-06 Drug substance 2024-07-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206229-001 11090186 2033-10-24 U-2348 2021-09-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206229-001 10028858 2034-03-22 U-2348 Drug product 2018-08-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206229-001 11571328 2040-09-07 Drug product 2023-02-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206229-001 12004992 2033-10-06 Drug substance 2024-07-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206229-001 11090186 2033-10-24 U-2348 2021-09-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206229-001 10028858 2034-03-22 U-2348 Drug product 2018-08-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206229-001 11571328 2040-09-07 Drug product 2023-02-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206229-001 12004992 2033-10-06 Drug substance 2024-07-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206229-001 11090186 2033-10-24 U-2348 2021-09-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206229-001 10028858 2034-03-22 U-2348 Drug product 2018-08-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206229-001 11571328 2040-09-07 Drug product 2023-02-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206229-001 12004992 2033-10-06 Drug substance 2024-07-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206229-001 11090186 2033-10-24 U-2348 2021-09-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206229-001 10028858 2034-03-22 U-2348 Drug product 2018-08-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206229-001 11571328 2040-09-07 Drug product 2023-02-27 d8e5a09893c0…
Observed Orange Book exclusivity history# 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0023-5858 LILETTA Levonorgestrel Allergan, Inc. NDA Current 0023-5858 LILETTA Levonorgestrel Allergan, Inc. NDA Current 0023-5858 LILETTA Levonorgestrel Allergan, Inc. NDA Current 0023-5858 LILETTA Levonorgestrel Allergan, Inc. NDA Current 0023-5858 LILETTA Levonorgestrel Allergan, Inc. NDA Current 0023-5858 LILETTA Levonorgestrel Allergan, Inc. NDA Current 52544-035 LILETTA Levonorgestrel Actavis Pharma, Inc. NDA Current 52544-035 LILETTA Levonorgestrel Actavis Pharma, Inc. NDA Current 52544-035 LILETTA Levonorgestrel Actavis Pharma, Inc. NDA Current