Application 091482

Type: ANDA
Sponsor: ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	CAPSULE, EXTENDED RELEASE;ORAL	100MG	No	No
002	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	CAPSULE, EXTENDED RELEASE;ORAL	150MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A091482-001	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23
A091482-002	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A091482-001	AB
A091482-002	AB

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 · 82 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	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A091482-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091482-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091482-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091482-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091482-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091482-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091482-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091482-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091482-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091482-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091482-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091482-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091482-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091482-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091482-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091482-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091482-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091482-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091482-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091482-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091482-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091482-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091482-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091482-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091482-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091482-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091482-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091482-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091482-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091482-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091482-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091482-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091482-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091482-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091482-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091482-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091482-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091482-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091482-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091482-002	AB	1	`782e0a99824c…`

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
Fluvoxamine Maleate	FLUVOXAMINE MALEATE	AvKARE	4527a684-51c0-1858-e063-6394a90a2631	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091482 application number: ANDA091482
Fluvoxamine Maleate	FLUVOXAMINE MALEATE	Actavis Pharma, Inc.	8bbd7e39-b9ab-4716-9522-aa8c4b92210e	2025-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091482 application number: ANDA091482 ndc (product): 0228-2849 ndc (product): 0228-2848

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0228-2848	Fluvoxamine Maleate	Fluvoxamine Maleate	Actavis Pharma, Inc.	ANDA	Current
0228-2848	Fluvoxamine Maleate	Fluvoxamine Maleate	Actavis Pharma, Inc.	ANDA	Current
0228-2849	Fluvoxamine Maleate	Fluvoxamine Maleate	Actavis Pharma, Inc.	ANDA	Current
0228-2849	Fluvoxamine Maleate	Fluvoxamine Maleate	Actavis Pharma, Inc.	ANDA	Current