Application 208224

Type: NDA
Sponsor: BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KYLEENA	LEVONORGESTREL	INTRAUTERINE DEVICE;INTRAUTERINE	19.5MG	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
N208224-001	KYLEENA	LEVONORGESTREL	19.5MG	SYSTEM / INTRAUTERINE		RLD, RS	2016-09-16

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208224-001	11628088	2027-02-07		Drug product	2023-08-24
N208224-001	11850182	2029-09-14	U-3819	Drug product	2024-02-29
N208224-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208224-001	KYLEENA	19.5MG	SYSTEM / INTRAUTERINE	RLD, RS	2016-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208224-001	KYLEENA	19.5MG	SYSTEM / INTRAUTERINE	RLD, RS	2016-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208224-001	KYLEENA	19.5MG	SYSTEM / INTRAUTERINE	RLD, RS	2016-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208224-001	KYLEENA	19.5MG	SYSTEM / INTRAUTERINE	RLD, RS	2016-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208224-001	KYLEENA	19.5MG	SYSTEM / INTRAUTERINE	RLD, RS	2016-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208224-001	KYLEENA	19.5MG	SYSTEM / INTRAUTERINE	RLD, RS	2016-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208224-001	KYLEENA	19.5MG	SYSTEM / INTRAUTERINE	RLD, RS	2016-09-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208224-001	KYLEENA	19.5MG	SYSTEM / INTRAUTERINE	RLD, RS	2016-09-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208224-001	KYLEENA	19.5MG	SYSTEM / INTRAUTERINE	RLD, RS	2016-09-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208224-001	KYLEENA	19.5MG	SYSTEM / INTRAUTERINE	RLD, RS	2016-09-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208224-001	KYLEENA	19.5MG	SYSTEM / INTRAUTERINE	RLD, RS	2016-09-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208224-001	KYLEENA	19.5MG	SYSTEM / INTRAUTERINE	RLD, RS	2016-09-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208224-001	KYLEENA	19.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2016-09-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208224-001	KYLEENA	19.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2016-09-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208224-001	KYLEENA	19.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2016-09-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208224-001	KYLEENA	19.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2016-09-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208224-001	KYLEENA	19.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2016-09-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208224-001	KYLEENA	19.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2016-09-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208224-001	KYLEENA	19.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2016-09-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208224-001	KYLEENA	19.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2016-09-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208224-001	KYLEENA	19.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2016-09-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208224-001	KYLEENA	19.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2016-09-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208224-001	KYLEENA	19.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2016-09-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208224-001	KYLEENA	19.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2016-09-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208224-001	KYLEENA	19.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2016-09-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208224-001	KYLEENA	19.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2016-09-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208224-001	KYLEENA	19.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2016-09-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208224-001	KYLEENA	19.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2016-09-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208224-001	KYLEENA	19.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2016-09-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208224-001	KYLEENA	19.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2016-09-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208224-001	KYLEENA	19.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2016-09-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208224-001	KYLEENA	19.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2016-09-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208224-001	KYLEENA	19.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2016-09-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208224-001	KYLEENA	19.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2016-09-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208224-001	KYLEENA	19.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2016-09-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208224-001	KYLEENA	19.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2016-09-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208224-001	KYLEENA	19.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2016-09-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208224-001	KYLEENA	19.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2016-09-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208224-001	KYLEENA	19.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2016-09-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208224-001	KYLEENA	19.5MG	INTRAUTERINE DEVICE / INTRAUTERINE	RLD, RS	2016-09-16	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 164 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	N208224-001	11628088	2027-02-07		Drug product	2023-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208224-001	11850182	2029-09-14	U-3819	Drug product	2024-02-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208224-001	10561524	2029-09-16	U-2948		2020-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208224-001	11628088	2027-02-07		Drug product	2023-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208224-001	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	N208224-001	10561524	2029-09-16	U-2948		2020-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208224-001	11628088	2027-02-07		Drug product	2023-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208224-001	11850182	2029-09-14	U-3819	Drug product	2024-02-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208224-001	10561524	2029-09-16	U-2948		2020-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208224-001	11628088	2027-02-07		Drug product	2023-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208224-001	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	N208224-001	10561524	2029-09-16	U-2948		2020-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208224-001	11628088	2027-02-07		Drug product	2023-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208224-001	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	N208224-001	10561524	2029-09-16	U-2948		2020-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208224-001	11628088	2027-02-07		Drug product	2023-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208224-001	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	N208224-001	10561524	2029-09-16	U-2948		2020-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208224-001	11628088	2027-02-07		Drug product	2023-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208224-001	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	N208224-001	10561524	2029-09-16	U-2948		2020-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208224-001	11628088	2027-02-07		Drug product	2023-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208224-001	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	N208224-001	10561524	2029-09-16	U-2948		2020-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208224-001	11628088	2027-02-07		Drug product	2023-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208224-001	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	N208224-001	10561524	2029-09-16	U-2948		2020-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208224-001	11628088	2027-02-07		Drug product	2023-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208224-001	11850182	2029-09-14	U-3819	Drug product	2024-02-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208224-001	10561524	2029-09-16	U-2948		2020-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208224-001	11628088	2027-02-07		Drug product	2023-08-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208224-001	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	N208224-001	10561524	2029-09-16	U-2948		2020-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208224-001	11628088	2027-02-07		Drug product	2023-08-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208224-001	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	N208224-001	10561524	2029-09-16	U-2948		2020-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208224-001	11628088	2027-02-07		Drug product	2023-08-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208224-001	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	N208224-001	10561524	2029-09-16	U-2948		2020-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208224-001	11628088	2027-02-07		Drug product	2023-08-24	`8072bd15b7f6…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N208224-001	NP	2019-09-16	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N208224-001	NP	2019-09-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208224-001	NP	2019-09-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208224-001	NP	2019-09-16	`ea99ee380514…`

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
Kyleena	LEVONORGESTREL	Bayer HealthCare Pharmaceuticals Inc.	2e07c155-21e1-4781-9633-ce8bddd47080	2025-10-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208224 application number: NDA208224 ndc (product): 50419-424

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50419-424	Kyleena	Levonorgestrel	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-424	Kyleena	Levonorgestrel	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-424	Kyleena	Levonorgestrel	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-424	Kyleena	Levonorgestrel	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-424	Kyleena	Levonorgestrel	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-424	Kyleena	Levonorgestrel	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-424	Kyleena	Levonorgestrel	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74182	SUPPL	2023-05-05
74179	SUPPL	2023-05-05
69870	SUPPL	2022-01-13
69834	SUPPL	2022-01-11
67187	SUPPL	2021-04-27
67080	SUPPL	2021-04-16
52814	SUPPL	2018-03-05
52794	SUPPL	2018-03-02
50198	ORIG	2017-10-26
45374	ORIG	2016-09-20
45373	ORIG	2016-09-20