Application 075900

Type: ANDA
Sponsor: ECI PHARMS LLC

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 1.

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
A075900-001	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2006-02-23
A075900-002	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2006-02-23
A075900-003	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2006-02-23

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 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075900-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2006-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075900-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2006-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075900-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2006-02-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075900-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2006-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075900-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2006-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075900-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2006-02-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075900-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2006-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075900-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2006-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075900-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2006-02-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075900-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2006-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075900-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2006-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075900-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2006-02-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075900-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2006-02-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075900-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2006-02-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075900-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2006-02-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075900-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2006-02-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075900-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2006-02-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075900-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2006-02-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075900-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2006-02-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075900-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2006-02-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075900-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2006-02-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075900-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2006-02-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075900-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2006-02-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075900-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2006-02-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075900-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2006-02-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075900-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2006-02-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075900-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2006-02-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075900-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2006-02-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075900-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2006-02-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075900-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2006-02-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075900-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2006-02-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075900-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2006-02-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075900-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2006-02-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075900-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2006-02-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075900-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2006-02-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075900-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2006-02-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075900-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2006-02-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075900-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2006-02-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075900-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2006-02-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075900-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2006-02-23	`8072bd15b7f6…`

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
Fluvoxamine Maleate	FLUVOXAMINE MALEATE	Chartwell RX, LLC	b8320308-084f-43fb-9b1d-5620a0efaf46	2025-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075900 application number: ANDA075900

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57664-357	FLUVOXAMINE MALEATE	fluvoxamine maleate	Caraco Pharmaceutical Laboratories, Ltd.	ANDA	Current
57664-361	FLUVOXAMINE MALEATE	fluvoxamine maleate	Caraco Pharmaceutical Laboratories, Ltd.	ANDA	Current
57664-362	FLUVOXAMINE MALEATE	fluvoxamine maleate	Caraco Pharmaceutical Laboratories, Ltd.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44278	ORIG	2006-03-02