Home Applications 204516 Application 204516
Type NDA
Sponsor SEBELA IRELAND LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BRISDELLE PAROXETINE MESYLATE CAPSULE;ORAL EQ 7.5MG BASE 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 N204516-001 BRISDELLE PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N204516-001 AB
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 N204516-001 8946251 2026-08-04 U-904 Drug substance, Drug product 2015-02-09 N204516-001 9393237 2026-08-04 U-904 2016-08-11 N204516-001 8658663 2029-04-06 U-904 Drug substance, Drug product 2014-03-04
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 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N204516-001 BRISDELLE EQ 7.5MG BASE CAPSULE / ORAL AB RLD, RS 2013-06-28 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Observed Orange Book patent history# Patent history page 1 of 5 · 168 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 N204516-001 8946251 2026-08-04 U-904 Drug substance, Drug product 2015-02-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204516-001 9393237 2026-08-04 U-904 2016-08-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204516-001 8658663 2029-04-06 U-904 Drug substance, Drug product 2014-03-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 N204516-001 8946251 2026-08-04 U-904 Drug substance, Drug product 2015-02-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204516-001 9393237 2026-08-04 U-904 2016-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204516-001 8658663 2029-04-06 U-904 Drug substance, Drug product 2014-03-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N204516-001 8946251 2026-08-04 U-904 Drug substance, Drug product 2015-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204516-001 9393237 2026-08-04 U-904 2016-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204516-001 8658663 2029-04-06 U-904 Drug substance, Drug product 2014-03-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204516-001 7598271 2025-05-04 Drug substance 2013-07-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204516-001 8946251 2026-08-04 U-904 Drug substance, Drug product 2015-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204516-001 9393237 2026-08-04 U-904 2016-08-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204516-001 8658663 2029-04-06 U-904 Drug substance, Drug product 2014-03-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204516-001 7598271 2025-05-04 Drug substance 2013-07-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204516-001 8946251 2026-08-04 U-904 Drug substance, Drug product 2015-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204516-001 9393237 2026-08-04 U-904 2016-08-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204516-001 8658663 2029-04-06 U-904 Drug substance, Drug product 2014-03-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204516-001 7598271 2025-05-04 Drug substance 2013-07-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204516-001 8946251 2026-08-04 U-904 Drug substance, Drug product 2015-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204516-001 9393237 2026-08-04 U-904 2016-08-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204516-001 8658663 2029-04-06 U-904 Drug substance, Drug product 2014-03-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204516-001 7598271 2025-05-04 Drug substance 2013-07-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204516-001 8946251 2026-08-04 U-904 Drug substance, Drug product 2015-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204516-001 9393237 2026-08-04 U-904 2016-08-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204516-001 8658663 2029-04-06 U-904 Drug substance, Drug product 2014-03-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204516-001 7598271 2025-05-04 Drug substance 2013-07-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204516-001 8946251 2026-08-04 U-904 Drug substance, Drug product 2015-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204516-001 9393237 2026-08-04 U-904 2016-08-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204516-001 8658663 2029-04-06 U-904 Drug substance, Drug product 2014-03-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204516-001 7598271 2025-05-04 Drug substance 2013-07-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204516-001 8946251 2026-08-04 U-904 Drug substance, Drug product 2015-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204516-001 9393237 2026-08-04 U-904 2016-08-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204516-001 8658663 2029-04-06 U-904 Drug substance, Drug product 2014-03-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204516-001 7598271 2025-05-04 Drug substance 2013-07-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204516-001 8946251 2026-08-04 U-904 Drug substance, Drug product 2015-02-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204516-001 9393237 2026-08-04 U-904 2016-08-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204516-001 8658663 2029-04-06 U-904 Drug substance, Drug product 2014-03-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204516-001 7598271 2025-05-04 Drug substance 2013-07-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204516-001 8946251 2026-08-04 U-904 Drug substance, Drug product 2015-02-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204516-001 9393237 2026-08-04 U-904 2016-08-11 d8e5a09893c0…
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 · 2 matching rows.
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 0574-0279 Paroxetine paroxetine Paddock Laboratories, LLC NDA Current 0574-0279 Paroxetine paroxetine Padagis US LLC NDA Current 54766-907 BRISDELLE paroxetine Sebela Pharmaceuticals Inc. NDA Current 54766-907 BRISDELLE paroxetine Sebela Pharmaceuticals Inc. NDA Current 54766-907 BRISDELLE paroxetine Sebela Pharmaceuticals Inc. NDA Current