Application 203279

Type: ANDA
Sponsor: APOTEX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PALIPERIDONE	PALIPERIDONE	TABLET, EXTENDED RELEASE;ORAL	3MG	No	No
002	PALIPERIDONE	PALIPERIDONE	TABLET, EXTENDED RELEASE;ORAL	6MG	No	No
003	PALIPERIDONE	PALIPERIDONE	TABLET, EXTENDED RELEASE;ORAL	9MG	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
A203279-001	PALIPERIDONE	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	2026-01-26
A203279-002	PALIPERIDONE	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	2026-01-26
A203279-003	PALIPERIDONE	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	2026-01-26

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	A203279-001	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL		2026-01-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203279-002	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL		2026-01-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203279-003	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL		2026-01-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203279-001	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL		2026-01-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203279-002	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL		2026-01-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203279-003	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL		2026-01-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203279-001	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2026-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203279-002	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2026-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203279-003	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2026-01-26	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203279-001	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL		2026-01-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203279-002	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL		2026-01-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203279-003	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL		2026-01-26	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203279-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203279-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203279-003	AB	1	`011fe1cb6892…`

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 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Paliperidone	PALIPERIDONE	Coupler LLC	313538c9-01d3-1558-e063-6394a90aa21d	2025-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Paliperidone generic name: PALIPERIDONE
paliperidone	PALIPERIDONE	Alembic Pharmaceuticals Inc.	45fc28d1-132f-413b-a407-dc90e1229ee2	2025-02-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: paliperidone generic name: PALIPERIDONE
INVEGA	PALIPERIDONE	Janssen Pharmaceuticals, Inc.	7b8e5b26-b9e4-4704-921b-3c3c0d159916	2025-01-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PALIPERIDONE
paliperidone	PALIPERIDONE	Alembic Pharmaceuticals Limited	be30f3cc-55fb-4a74-9778-60573a7f18c6	2024-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: paliperidone generic name: PALIPERIDONE
Paliperidone	PALIPERIDONE	Tris Pharma Inc	d7033e52-3df2-48e2-adda-15a57c2f148f	2024-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Paliperidone generic name: PALIPERIDONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.