Home Applications 021225 Application 021225
Type NDA
Sponsor BAYER HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MIRENA LEVONORGESTREL INTRAUTERINE DEVICE;INTRAUTERINE 52MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N021225-001 MIRENA LEVONORGESTREL 52MG SYSTEM / INTRAUTERINE RLD, RS 2000-12-06
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021225-001 11850182 2029-09-14 U-3819 Drug product 2024-02-29 N021225-001 10561524 2029-09-16 U-2948 2020-09-28
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N021225-001 MIRENA 52MG SYSTEM / INTRAUTERINE RLD, RS 2000-12-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021225-001 MIRENA 52MG SYSTEM / INTRAUTERINE RLD, RS 2000-12-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021225-001 MIRENA 52MG SYSTEM / INTRAUTERINE RLD, RS 2000-12-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021225-001 MIRENA 52MG SYSTEM / INTRAUTERINE RLD, RS 2000-12-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021225-001 MIRENA 52MG SYSTEM / INTRAUTERINE RLD, RS 2000-12-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021225-001 MIRENA 52MG SYSTEM / INTRAUTERINE RLD, RS 2000-12-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021225-001 MIRENA 52MG SYSTEM / INTRAUTERINE RLD, RS 2000-12-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021225-001 MIRENA 52MG SYSTEM / INTRAUTERINE RLD, RS 2000-12-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021225-001 MIRENA 52MG SYSTEM / INTRAUTERINE RLD, RS 2000-12-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021225-001 MIRENA 52MG SYSTEM / INTRAUTERINE RLD, RS 2000-12-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021225-001 MIRENA 52MG SYSTEM / INTRAUTERINE RLD, RS 2000-12-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021225-001 MIRENA 52MG SYSTEM / INTRAUTERINE RLD, RS 2000-12-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021225-001 MIRENA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2000-12-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021225-001 MIRENA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2000-12-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021225-001 MIRENA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2000-12-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021225-001 MIRENA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2000-12-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021225-001 MIRENA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2000-12-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021225-001 MIRENA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2000-12-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021225-001 MIRENA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2000-12-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021225-001 MIRENA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2000-12-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021225-001 MIRENA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2000-12-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021225-001 MIRENA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2000-12-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021225-001 MIRENA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2000-12-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021225-001 MIRENA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2000-12-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021225-001 MIRENA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2000-12-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021225-001 MIRENA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2000-12-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021225-001 MIRENA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2000-12-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021225-001 MIRENA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2000-12-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021225-001 MIRENA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2000-12-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021225-001 MIRENA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2000-12-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021225-001 MIRENA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2000-12-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021225-001 MIRENA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2000-12-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021225-001 MIRENA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2000-12-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021225-001 MIRENA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2000-12-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021225-001 MIRENA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2000-12-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021225-001 MIRENA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2000-12-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021225-001 MIRENA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2000-12-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021225-001 MIRENA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2000-12-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021225-001 MIRENA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2000-12-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021225-001 MIRENA 52MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2000-12-06 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 3 · 120 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021225-001 11850182 2029-09-14 U-3819 Drug product 2024-02-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021225-001 10561524 2029-09-16 U-2948 2020-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021225-001 11850182 2029-09-14 U-3819 Drug product 2024-02-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021225-001 10561524 2029-09-16 U-2948 2020-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021225-001 11850182 2029-09-14 U-3819 Drug product 2024-02-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021225-001 10561524 2029-09-16 U-2948 2020-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021225-001 11850182 2029-09-14 U-3819 Drug product 2024-02-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021225-001 10561524 2029-09-16 U-2948 2020-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021225-001 11850182 2029-09-14 U-3819 Drug product 2024-02-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021225-001 10561524 2029-09-16 U-2948 2020-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021225-001 11850182 2029-09-14 U-3819 Drug product 2024-02-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021225-001 10561524 2029-09-16 U-2948 2020-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021225-001 11850182 2029-09-14 U-3819 Drug product 2024-02-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021225-001 10561524 2029-09-16 U-2948 2020-09-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021225-001 11850182 2029-09-14 U-3819 Drug product 2024-02-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021225-001 10561524 2029-09-16 U-2948 2020-09-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021225-001 11850182 2029-09-14 U-3819 Drug product 2024-02-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021225-001 10561524 2029-09-16 U-2948 2020-09-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021225-001 11850182 2029-09-14 U-3819 Drug product 2024-02-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021225-001 10561524 2029-09-16 U-2948 2020-09-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021225-001 11850182 2029-09-14 U-3819 Drug product 2024-02-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021225-001 10561524 2029-09-16 U-2948 2020-09-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021225-001 11850182 2029-09-14 U-3819 Drug product 2024-02-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021225-001 10561524 2029-09-16 U-2948 2020-09-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021225-001 11850182 2029-09-14 U-3819 Drug product 2024-02-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021225-001 10561524 2029-09-16 U-2948 2020-09-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021225-001 11850182 2029-09-14 U-3819 Drug product 2024-02-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021225-001 10561524 2029-09-16 U-2948 2020-09-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021225-001 10561524 2029-09-16 U-2948 2020-09-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021225-001 9615965 2029-09-16 U-2003 Drug product 2017-05-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021225-001 10987244 2031-04-01 Drug product 2021-05-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021225-001 9668912 2031-04-01 Drug product 2017-06-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021225-001 10561524 2029-09-16 U-2948 2020-09-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021225-001 9615965 2029-09-16 U-2003 Drug product 2017-05-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021225-001 10987244 2031-04-01 Drug product 2021-05-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021225-001 9668912 2031-04-01 Drug product 2017-06-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021225-001 10561524 2029-09-16 U-2948 2020-09-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021225-001 9615965 2029-09-16 U-2003 Drug product 2017-05-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021225-001 10987244 2031-04-01 Drug product 2021-05-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021225-001 9668912 2031-04-01 Drug product 2017-06-28 4b0b4de00fa7…
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mirena LEVONORGESTREL Bayer HealthCare Pharmaceuticals Inc. dcbd6aa2-b3fa-479a-a676-56ea742962fc 2025-10-29 Warnings, Adverse reactions Exact identifier application applno (NDA): 021225 application number: NDA021225 ndc (product): 50419-423
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50419-423 Mirena Levonorgestrel Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-423 Mirena Levonorgestrel Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-423 Mirena Levonorgestrel Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-423 Mirena Levonorgestrel Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-423 Mirena Levonorgestrel Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-423 Mirena Levonorgestrel Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-423 Mirena Levonorgestrel Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-423 Mirena Levonorgestrel Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-423 Mirena Levonorgestrel Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-423 Mirena Levonorgestrel Bayer HealthCare Pharmaceuticals Inc. NDA Current