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 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
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 · 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	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…`
2022-09-29 23:25 UTC	2022-09	N204516-001	BRISDELLE	EQ 7.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2013-06-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N204516-001	BRISDELLE	EQ 7.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2013-06-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204516-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204516-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204516-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204516-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204516-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204516-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204516-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204516-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204516-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204516-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204516-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204516-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204516-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204516-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204516-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204516-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204516-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204516-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204516-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204516-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204516-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204516-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204516-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204516-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204516-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204516-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204516-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204516-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204516-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204516-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204516-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204516-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204516-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204516-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204516-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204516-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204516-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204516-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204516-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N204516-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 162 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	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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204516-001	8658663	2029-04-06	U-904	Drug substance, Drug product	2014-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204516-001	7598271	2025-05-04		Drug substance	2013-07-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204516-001	8946251	2026-08-04	U-904	Drug substance, Drug product	2015-02-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204516-001	9393237	2026-08-04	U-904		2016-08-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204516-001	8658663	2029-04-06	U-904	Drug substance, Drug product	2014-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204516-001	7598271	2025-05-04		Drug substance	2013-07-11	`79d66fd596c7…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BRISDELLE	PAROXETINE	Legacy Pharma USA, Inc.	502311b3-b617-4cbd-a3ab-a60f2c62880a	2025-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204516 application number: NDA204516
Paroxetine	PAROXETINE	Padagis US LLC	1383d713-79b9-45bd-bd06-65707f28bc99	2023-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204516 application number: NDA204516 ndc (product): 0574-0279

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81243	SUPPL	2025-02-14
81242	SUPPL	2025-02-14
81241	SUPPL	2025-02-14
81224	SUPPL	2025-02-12
81223	SUPPL	2025-02-12
75224	SUPPL	2023-08-22
75218	SUPPL	2023-08-22
68719	SUPPL	2021-09-22
68676	SUPPL	2021-09-21
68675	SUPPL	2021-09-21
48201	SUPPL	2017-05-02
48178	SUPPL	2017-05-01
48177	SUPPL	2017-05-01
46834	SUPPL	2017-01-13
46722	SUPPL	2017-01-06
19569	SUPPL	2014-12-03
32567	SUPPL	2014-12-02
44904	ORIG	2014-07-25
43467	ORIG	2014-07-25
40396	ORIG	2013-07-10
32566	ORIG	2013-07-02