Home Applications 204017 Application 204017
Type NDA
Sponsor AGILE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TWIRLA ETHINYL ESTRADIOL; LEVONORGESTREL SYSTEM;TRANSDERMAL 0.03MG/24HR;0.12MG/24HR Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N204017-001 TWIRLA ETHINYL ESTRADIOL; LEVONORGESTREL 0.01MG/24HR;0.04MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14
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 N204017-001 8747888 2028-07-10 Drug product 2020-03-10 N204017-001 9050348 2028-07-10 Drug product 2020-03-10 N204017-001 8246978 2028-08-26 Drug product 2020-03-10
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 2026-09-14 22:38:34 2026-08 N204017-001 TWIRLA 0.01MG/24HR;0.04MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N204017-001 TWIRLA 0.01MG/24HR;0.04MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N204017-001 TWIRLA 0.03MG/24HR;0.12MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N204017-001 TWIRLA 0.01MG/24HR;0.04MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2020-02-14 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 139 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N204017-001 8747888 2028-07-10 Drug product 2020-03-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204017-001 9050348 2028-07-10 Drug product 2020-03-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204017-001 8246978 2028-08-26 Drug product 2020-03-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N204017-001 8747888 2028-07-10 Drug product 2020-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204017-001 9050348 2028-07-10 Drug product 2020-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204017-001 8246978 2028-08-26 Drug product 2020-03-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N204017-001 8747888 2028-07-10 Drug product 2020-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204017-001 9050348 2028-07-10 Drug product 2020-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204017-001 8246978 2028-08-26 Drug product 2020-03-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204017-001 8747888 2028-07-10 Drug product 2020-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204017-001 9050348 2028-07-10 Drug product 2020-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204017-001 8246978 2028-08-26 Drug product 2020-03-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204017-001 8747888 2028-07-10 Drug product 2020-03-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204017-001 9050348 2028-07-10 Drug product 2020-03-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204017-001 8246978 2028-08-26 Drug product 2020-03-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204017-001 8747888 2028-07-10 Drug product 2020-03-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204017-001 9050348 2028-07-10 Drug product 2020-03-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204017-001 8246978 2028-08-26 Drug product 2020-03-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204017-001 8747888 2028-07-10 Drug product 2020-03-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204017-001 9050348 2028-07-10 Drug product 2020-03-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204017-001 8246978 2028-08-26 Drug product 2020-03-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204017-001 8747888 2028-07-10 Drug product 2020-03-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204017-001 9050348 2028-07-10 Drug product 2020-03-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204017-001 8246978 2028-08-26 Drug product 2020-03-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204017-001 8747888 2028-07-10 Drug product 2020-03-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204017-001 9050348 2028-07-10 Drug product 2020-03-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204017-001 8246978 2028-08-26 Drug product 2020-03-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204017-001 8747888 2028-07-10 Drug product 2020-03-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204017-001 9050348 2028-07-10 Drug product 2020-03-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204017-001 8246978 2028-08-26 Drug product 2020-03-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204017-001 8747888 2028-07-10 Drug product 2020-03-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204017-001 9050348 2028-07-10 Drug product 2020-03-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204017-001 8246978 2028-08-26 Drug product 2020-03-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204017-001 8747888 2028-07-10 Drug product 2020-03-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204017-001 9050348 2028-07-10 Drug product 2020-03-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204017-001 8246978 2028-08-26 Drug product 2020-03-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204017-001 8747888 2028-07-10 Drug product 2020-03-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204017-001 9050348 2028-07-10 Drug product 2020-03-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204017-001 8246978 2028-08-26 Drug product 2020-03-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204017-001 8747888 2028-07-10 Drug product 2020-03-10 301d65b070ca…
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 Twirla LEVONORGESTREL/ETHINYL ESTRADIOL Agile Therapeutics, Inc. bcaf8db0-1750-425d-b008-255b5e7a9cc6 2026-06-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 204017 application number: NDA204017 ndc (product): 71671-100
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 71671-100 Twirla levonorgestrel/ethinyl estradiol Agile Therapeutics, Inc. NDA Current 71671-100 Twirla levonorgestrel/ethinyl estradiol Agile Therapeutics, Inc. NDA Current 71671-100 Twirla levonorgestrel/ethinyl estradiol Agile Therapeutics, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 84204 SUPPL 2025-11-19 70947 SUPPL 2022-05-03 70890 SUPPL 2022-05-02 62745 ORIG 2020-04-30 61905 ORIG 2020-02-18 61904 ORIG 2020-02-18