Application 220328

Type: ANDA
Sponsor: APPCO

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	No

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

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
A220328-001	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2026-04-30
A220328-002	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2026-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A220328-001	AB
A220328-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A220328-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2026-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A220328-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2026-04-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A220328-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2026-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A220328-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2026-04-30	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A220328-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2026-04-30	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A220328-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2026-04-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A220328-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A220328-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A220328-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A220328-002	AB	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A220328-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A220328-002	AB	1	`a50c72e98297…`

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.