Application 022033

Type: NDA
Sponsor: JAZZ PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LUVOX CR	FLUVOXAMINE MALEATE	CAPSULE, EXTENDED RELEASE;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	LUVOX CR	FLUVOXAMINE MALEATE	CAPSULE, EXTENDED RELEASE;ORAL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022033-001	LUVOX CR	FLUVOXAMINE MALEATE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2008-02-28
N022033-002	LUVOX CR	FLUVOXAMINE MALEATE	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2008-02-28

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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022033-001	LUVOX CR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022033-002	LUVOX CR	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022033-001	LUVOX CR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022033-002	LUVOX CR	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022033-001	LUVOX CR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022033-002	LUVOX CR	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022033-001	LUVOX CR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022033-002	LUVOX CR	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022033-001	LUVOX CR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022033-002	LUVOX CR	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022033-001	LUVOX CR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022033-002	LUVOX CR	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022033-001	LUVOX CR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022033-002	LUVOX CR	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022033-001	LUVOX CR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022033-002	LUVOX CR	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022033-001	LUVOX CR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022033-002	LUVOX CR	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022033-001	LUVOX CR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022033-002	LUVOX CR	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022033-001	LUVOX CR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022033-002	LUVOX CR	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022033-001	LUVOX CR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022033-002	LUVOX CR	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022033-001	LUVOX CR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022033-002	LUVOX CR	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022033-001	LUVOX CR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022033-002	LUVOX CR	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022033-001	LUVOX CR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022033-002	LUVOX CR	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022033-001	LUVOX CR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022033-002	LUVOX CR	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022033-001	LUVOX CR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022033-002	LUVOX CR	150MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022033-001	LUVOX CR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022033-002	LUVOX CR	150MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022033-001	LUVOX CR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022033-002	LUVOX CR	150MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022033-001	LUVOX CR	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022033-002	LUVOX CR	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2008-02-28	`bb7c543d1eb4…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022033-001	7465462	2020-05-10	U-929	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022033-002	7465462	2020-05-10	U-929	Drug product	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N022033-001	7465462	2020-05-10	U-929	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022033-002	7465462	2020-05-10	U-929	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022033-001	7465462	2020-05-10	U-929	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022033-002	7465462	2020-05-10	U-929	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022033-001	7465462	2020-05-10	U-929	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022033-002	7465462	2020-05-10	U-929	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022033-001	7465462	2020-05-10	U-929	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022033-002	7465462	2020-05-10	U-929	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022033-001	7465462	2020-05-10	U-929	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022033-002	7465462	2020-05-10	U-929	Drug product	`ea99ee380514…`

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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluvoxamine Maleate	FLUVOXAMINE MALEATE	Par Health USA, LLC	d492230c-f56a-4759-ba86-7090b9f44063	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUVOXAMINE MALEATE
Fluvoxamine Maleate	FLUVOXAMINE MALEATE	American Health Packaging	0b107225-ed5a-4461-9184-f3f2bad1892f	2026-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUVOXAMINE MALEATE
fluvoxamine maleate	FLUVOXAMINE MALEATE	REMEDYREPACK INC.	5198b1c8-8dd6-4b8f-bd85-294ac468af53	2026-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUVOXAMINE MALEATE
Fluvoxamine Maleate	FLUVOXAMINE MALEATE	Preferred Pharmaceuticals Inc.	a4e0212a-ce68-4466-a0e4-f87d5d9ff0b3	2026-04-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUVOXAMINE MALEATE
fluvoxamine maleate	FLUVOXAMINE MALEATE	Preferred Pharmaceuticals, Inc.	b5b2128d-2363-4966-971f-83219755ecd7	2026-04-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUVOXAMINE MALEATE
Fluvoxamine maleate	FLUVOXAMINE MALEATE	Bryant Ranch Prepack	c3d59ca9-dd42-4b1c-bd2d-23eb507598b8	2026-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUVOXAMINE MALEATE
Fluvoxamine Maleate	FLUVOXAMINE MALEATE	Bryant Ranch Prepack	4239fc32-e5cb-4393-b90c-742db42b5d07	2026-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUVOXAMINE MALEATE
Fluvoxamine Maleate	FLUVOXAMINE MALEATE	Bryant Ranch Prepack	47daea9e-545d-4a67-b2b2-d12c3c98734b	2026-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUVOXAMINE MALEATE
fluvoxamine maleate	FLUVOXAMINE MALEATE	REMEDYREPACK INC.	88b5207a-d87b-4541-ac6b-aa1c51715fcf	2026-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUVOXAMINE MALEATE
Fluvoxamine Maleate	FLUVOXAMINE MALEATE	AvKARE	4527a684-51c0-1858-e063-6394a90a2631	2025-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUVOXAMINE MALEATE
Fluvoxamine Maleate	FLUVOXAMINE MALEATE	Ajanta Pharma USA Inc.	0a6836ab-bd0e-410b-82af-07720e386532	2025-11-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUVOXAMINE MALEATE
Fluvoxamine maleate	FLUVOXAMINE MALEATE	A-S Medication Solutions	35b377d9-5b7a-4d8e-b6c1-4291d02f5dae	2025-10-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUVOXAMINE MALEATE
Fluvoxamine Maleate	FLUVOXAMINE MALEATE	PD-Rx Pharmaceuticals, Inc.	9972efbb-46cd-45b7-b71c-35032311b70c	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUVOXAMINE MALEATE
Fluvoxamine Maleate	FLUVOXAMINE MALEATE	Apotex Corp	6eeb14df-6fcf-a737-5359-5744eb4accea	2025-09-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUVOXAMINE MALEATE
Fluvoxamine maleate	FLUVOXAMINE MALEATE	Preferred Pharmaceuticals Inc.	642b7b5e-9f1c-479b-b9b3-bf06774f7b60	2025-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUVOXAMINE MALEATE
Fluvoxamine Maleate	FLUVOXAMINE MALEATE	Camber Pharmaceuticals, Inc.	e5574f41-d4df-42d5-baae-b317fb7c88bf	2025-08-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUVOXAMINE MALEATE
fluvoxamine maleate	FLUVOXAMINE MALEATE	ANI Pharmaceuticals, Inc.	7ecd83ec-88f5-4f85-9cc2-9068375d8820	2025-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUVOXAMINE MALEATE
fluvoxamine maleate	FLUVOXAMINE MALEATE	A-S Medication Solutions	ddc9e7e8-f041-43bb-970b-cd4b30367637	2025-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUVOXAMINE MALEATE
Fluvoxamine Maleate	FLUVOXAMINE MALEATE	Actavis Pharma, Inc.	8bbd7e39-b9ab-4716-9522-aa8c4b92210e	2025-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUVOXAMINE MALEATE
Fluvoxamine maleate	FLUVOXAMINE MALEATE	Bionpharma Inc.	191912e6-b3c8-be1a-e063-6394a90a8dd4	2025-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUVOXAMINE MALEATE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
46797	SUPPL	2017-01-11
46796	SUPPL	2017-01-11
46720	SUPPL	2017-01-06
6737	SUPPL	2014-07-24
38115	SUPPL	2014-07-23
38114	SUPPL	2012-12-04
29117	SUPPL	2012-12-04
23693	ORIG	2012-02-13
29116	SUPPL	2011-05-11
29115	SUPPL	2011-05-11
6736	SUPPL	2011-05-11
16808	SUPPL	2011-05-09
16807	SUPPL	2011-05-09
16806	SUPPL	2011-05-09
38113	SUPPL	2009-03-17
6735	SUPPL	2009-02-27
24234	ORIG	2008-08-11
21913	ORIG	2008-08-11
16805	ORIG	2008-03-05
6734	ORIG	2008-03-04