Home Applications 203159 Application 203159
Type NDA
Sponsor BAYER HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SKYLA LEVONORGESTREL INTRAUTERINE DEVICE;INTRAUTERINE 13.5MG 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 N203159-001 SKYLA LEVONORGESTREL 13.5MG SYSTEM / INTRAUTERINE RLD, RS 2013-01-09
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 N203159-001 11628088 2027-02-07 Drug product 2023-08-24 N203159-001 11850182 2029-09-14 U-3819 Drug product 2024-02-29 N203159-001 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 N203159-001 SKYLA 13.5MG SYSTEM / INTRAUTERINE RLD, RS 2013-01-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203159-001 SKYLA 13.5MG SYSTEM / INTRAUTERINE RLD, RS 2013-01-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203159-001 SKYLA 13.5MG SYSTEM / INTRAUTERINE RLD, RS 2013-01-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203159-001 SKYLA 13.5MG SYSTEM / INTRAUTERINE RLD, RS 2013-01-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203159-001 SKYLA 13.5MG SYSTEM / INTRAUTERINE RLD, RS 2013-01-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203159-001 SKYLA 13.5MG SYSTEM / INTRAUTERINE RLD, RS 2013-01-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203159-001 SKYLA 13.5MG SYSTEM / INTRAUTERINE RLD, RS 2013-01-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203159-001 SKYLA 13.5MG SYSTEM / INTRAUTERINE RLD, RS 2013-01-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203159-001 SKYLA 13.5MG SYSTEM / INTRAUTERINE RLD, RS 2013-01-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203159-001 SKYLA 13.5MG SYSTEM / INTRAUTERINE RLD, RS 2013-01-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203159-001 SKYLA 13.5MG SYSTEM / INTRAUTERINE RLD, RS 2013-01-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203159-001 SKYLA 13.5MG SYSTEM / INTRAUTERINE RLD, RS 2013-01-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203159-001 SKYLA 13.5MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2013-01-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203159-001 SKYLA 13.5MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2013-01-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203159-001 SKYLA 13.5MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2013-01-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203159-001 SKYLA 13.5MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2013-01-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203159-001 SKYLA 13.5MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2013-01-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203159-001 SKYLA 13.5MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2013-01-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203159-001 SKYLA 13.5MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2013-01-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203159-001 SKYLA 13.5MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2013-01-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203159-001 SKYLA 13.5MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2013-01-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N203159-001 SKYLA 13.5MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2013-01-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N203159-001 SKYLA 13.5MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2013-01-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N203159-001 SKYLA 13.5MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2013-01-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N203159-001 SKYLA 13.5MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2013-01-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N203159-001 SKYLA 13.5MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2013-01-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N203159-001 SKYLA 13.5MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2013-01-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N203159-001 SKYLA 13.5MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2013-01-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N203159-001 SKYLA 13.5MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2013-01-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N203159-001 SKYLA 13.5MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2013-01-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N203159-001 SKYLA 13.5MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2013-01-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N203159-001 SKYLA 13.5MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2013-01-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N203159-001 SKYLA 13.5MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2013-01-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N203159-001 SKYLA 13.5MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2013-01-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N203159-001 SKYLA 13.5MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2013-01-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N203159-001 SKYLA 13.5MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2013-01-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N203159-001 SKYLA 13.5MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2013-01-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N203159-001 SKYLA 13.5MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2013-01-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N203159-001 SKYLA 13.5MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2013-01-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N203159-001 SKYLA 13.5MG INTRAUTERINE DEVICE / INTRAUTERINE RLD, RS 2013-01-09 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 N203159-001 11628088 2027-02-07 Drug product 2023-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203159-001 11850182 2029-09-14 U-3819 Drug product 2024-02-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203159-001 10561524 2029-09-16 U-2948 2020-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203159-001 11628088 2027-02-07 Drug product 2023-08-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203159-001 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 N203159-001 10561524 2029-09-16 U-2948 2020-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203159-001 11628088 2027-02-07 Drug product 2023-08-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203159-001 11850182 2029-09-14 U-3819 Drug product 2024-02-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203159-001 10561524 2029-09-16 U-2948 2020-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203159-001 11628088 2027-02-07 Drug product 2023-08-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203159-001 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 N203159-001 10561524 2029-09-16 U-2948 2020-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203159-001 11628088 2027-02-07 Drug product 2023-08-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203159-001 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 N203159-001 10561524 2029-09-16 U-2948 2020-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203159-001 11628088 2027-02-07 Drug product 2023-08-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203159-001 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 N203159-001 10561524 2029-09-16 U-2948 2020-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203159-001 11628088 2027-02-07 Drug product 2023-08-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203159-001 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 N203159-001 10561524 2029-09-16 U-2948 2020-09-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203159-001 11628088 2027-02-07 Drug product 2023-08-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203159-001 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 N203159-001 10561524 2029-09-16 U-2948 2020-09-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203159-001 11628088 2027-02-07 Drug product 2023-08-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203159-001 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 N203159-001 10561524 2029-09-16 U-2948 2020-09-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203159-001 11628088 2027-02-07 Drug product 2023-08-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203159-001 11850182 2029-09-14 U-3819 Drug product 2024-02-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203159-001 10561524 2029-09-16 U-2948 2020-09-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203159-001 11628088 2027-02-07 Drug product 2023-08-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203159-001 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 N203159-001 10561524 2029-09-16 U-2948 2020-09-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203159-001 11628088 2027-02-07 Drug product 2023-08-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203159-001 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 N203159-001 10561524 2029-09-16 U-2948 2020-09-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203159-001 11628088 2027-02-07 Drug product 2023-08-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203159-001 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 N203159-001 10561524 2029-09-16 U-2948 2020-09-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203159-001 11628088 2027-02-07 Drug product 2023-08-24 8072bd15b7f6…
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 Skyla LEVONORGESTREL Bayer HealthCare Pharmaceuticals Inc. 9f44ff35-e052-49cd-a1c2-0bfd87d49309 2026-03-04 Warnings, Adverse reactions Exact identifier application applno (NDA): 203159 application number: NDA203159 ndc (product): 50419-422
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50419-422 Skyla Levonorgestrel Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-422 Skyla Levonorgestrel Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-422 Skyla Levonorgestrel Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-422 Skyla Levonorgestrel Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-422 Skyla Levonorgestrel Bayer HealthCare Pharmaceuticals Inc. NDA Current 50419-422 Skyla Levonorgestrel Bayer HealthCare Pharmaceuticals Inc. NDA Current