Home Applications 022526 Application 022526
Type NDA
Sponsor SPROUT PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ADDYI FLIBANSERIN TABLET;ORAL 100MG 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 N022526-001 ADDYI FLIBANSERIN 100MG TABLET / ORAL RLD, RS 2015-08-18
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022526-001 7151103 2028-05-09 U-1734 2015-09-14
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N022526-001 I-983 2028-12-13
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 · 43 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 2026-09-14 22:38:34 2026-08 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022526-001 ADDYI 100MG TABLET / ORAL RLD, RS 2015-08-18 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 3 · 103 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 N022526-001 7151103 2028-05-09 U-1734 2015-09-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022526-001 7151103 2028-05-09 U-1734 2015-09-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022526-001 7151103 2028-05-09 U-1734 2015-09-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022526-001 7151103 2028-05-09 U-1734 2015-09-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022526-001 7151103 2028-05-09 U-1734 2015-09-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022526-001 7151103 2028-05-09 U-1734 2015-09-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022526-001 7151103 2028-05-09 U-1734 2015-09-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022526-001 7151103 2028-05-09 U-1734 2015-09-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022526-001 7151103 2028-05-09 U-1734 2015-09-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022526-001 7151103 2028-05-09 U-1734 2015-09-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022526-001 7151103 2028-05-09 U-1734 2015-09-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022526-001 7151103 2028-05-09 U-1734 2015-09-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022526-001 7151103 2028-05-09 U-1734 2015-09-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022526-001 7151103 2028-05-09 U-1734 2015-09-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022526-001 7151103 2028-05-09 U-1734 2015-09-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022526-001 7151103 2028-05-09 U-1734 2015-09-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022526-001 7420057 2022-08-01 Drug substance, Drug product 2015-09-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022526-001 9468639 2022-10-16 U-1734 2016-11-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022526-001 7151103 2023-05-09 U-1734 2015-09-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022526-001 8227471 2023-05-09 U-1734 2015-09-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022526-001 7420057 2022-08-01 Drug substance, Drug product 2015-09-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022526-001 9468639 2022-10-16 U-1734 2016-11-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022526-001 7151103 2023-05-09 U-1734 2015-09-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022526-001 8227471 2023-05-09 U-1734 2015-09-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022526-001 7420057 2022-08-01 Drug substance, Drug product 2015-09-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022526-001 9468639 2022-10-16 U-1734 2016-11-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022526-001 7151103 2023-05-09 U-1734 2015-09-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022526-001 8227471 2023-05-09 U-1734 2015-09-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022526-001 7420057 2022-08-01 Drug substance, Drug product 2015-09-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022526-001 9468639 2022-10-16 U-1734 2016-11-08 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022526-001 7151103 2023-05-09 U-1734 2015-09-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022526-001 8227471 2023-05-09 U-1734 2015-09-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022526-001 7420057 2022-08-01 Drug substance, Drug product 2015-09-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022526-001 9468639 2022-10-16 U-1734 2016-11-08 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022526-001 7151103 2023-05-09 U-1734 2015-09-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022526-001 8227471 2023-05-09 U-1734 2015-09-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022526-001 7420057 2022-08-01 Drug substance, Drug product 2015-09-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022526-001 9468639 2022-10-16 U-1734 2016-11-08 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022526-001 7151103 2023-05-09 U-1734 2015-09-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022526-001 8227471 2023-05-09 U-1734 2015-09-14 782e0a99824c…
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 ADDYI FLIBANSERIN Sprout Pharmaceuticals, Inc. 3819daf3-e935-2c53-c527-e1d57922f394 2025-12-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022526 application number: NDA022526 ndc (product): 58604-214
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 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 58604-214 ADDYI flibanserin Sprout Pharmaceuticals, Inc. NDA Current 58604-214 ADDYI flibanserin Sprout Pharmaceuticals, Inc. NDA Current 58604-214 ADDYI flibanserin Sprout Pharmaceuticals, Inc. NDA Current 58604-214 ADDYI flibanserin Sprout Pharmaceuticals, Inc. NDA Current 58604-214 ADDYI flibanserin Sprout Pharmaceuticals, Inc. NDA Current