Application 075893

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	TABLET;ORAL	25MG	No	No
002	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	TABLET;ORAL	50MG	No	No
003	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	TABLET;ORAL	100MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A075893-001	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2002-09-10
A075893-002	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2002-09-10
A075893-003	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2002-09-10

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.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075893-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2002-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075893-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2002-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075893-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2002-09-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075893-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2002-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075893-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2002-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075893-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2002-09-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075893-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2002-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075893-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2002-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075893-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2002-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075893-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2002-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075893-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2002-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075893-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2002-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075893-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2002-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075893-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2002-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075893-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2002-09-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075893-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2002-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075893-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2002-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075893-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2002-09-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075893-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2002-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075893-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2002-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075893-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2002-09-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075893-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2002-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075893-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2002-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075893-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2002-09-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075893-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2002-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075893-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2002-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075893-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2002-09-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075893-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2002-09-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075893-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2002-09-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075893-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2002-09-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075893-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2002-09-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075893-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2002-09-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075893-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2002-09-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075893-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2002-09-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075893-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2002-09-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075893-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2002-09-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075893-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2002-09-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075893-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2002-09-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075893-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2002-09-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075893-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2002-09-10	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075893-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075893-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075893-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A075893-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075893-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075893-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075893-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075893-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075893-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075893-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075893-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075893-003	AB	1	`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 2 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluvoxamine Maleate	FLUVOXAMINE MALEATE	Chartwell RX, LLC	b8320308-084f-43fb-9b1d-5620a0efaf46	2025-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluvoxamine Maleate generic name: FLUVOXAMINE MALEATE
Fluvoxamine Maleate	FLUVOXAMINE MALEATE	Bionpharma Inc.	9924422b-7c90-42bf-a680-ffd92063d5f0	2024-05-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluvoxamine Maleate generic name: FLUVOXAMINE MALEATE

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-7569	Fluvoxamine Maleate	Fluvoxamine Maleate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44275	ORIG	2007-05-09