Application 216655

Type: NDA
Sponsor: XIAMEN LP PHARM CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OPIPZA	ARIPIPRAZOLE	FILM;ORAL	2MG	Yes	No
002	OPIPZA	ARIPIPRAZOLE	FILM;ORAL	5MG	Yes	No
003	OPIPZA	ARIPIPRAZOLE	FILM;ORAL	10MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	RLD / RS	Approval date
N216655-001	OPIPZA	ARIPIPRAZOLE	2MG	FILM / ORAL	RLD	2024-07-22
N216655-002	OPIPZA	ARIPIPRAZOLE	5MG	FILM / ORAL	RLD	2024-07-22
N216655-003	OPIPZA	ARIPIPRAZOLE	10MG	FILM / ORAL	RLD, RS	2024-07-22

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N216655-001	11331315	2040-11-03	Drug product	2024-11-12
N216655-001	11701352	2041-12-15	Drug product	2024-11-12
N216655-002	11331315	2040-11-03	Drug product	2024-11-12
N216655-002	11701352	2041-12-15	Drug product	2024-11-12
N216655-003	11331315	2040-11-03	Drug product	2024-11-12
N216655-003	11701352	2041-12-15	Drug product	2024-11-12

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N216655-001	OPIPZA	2MG	FILM / ORAL	RLD	2024-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216655-002	OPIPZA	5MG	FILM / ORAL	RLD	2024-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216655-003	OPIPZA	10MG	FILM / ORAL	RLD, RS	2024-07-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216655-001	OPIPZA	2MG	FILM / ORAL	RLD	2024-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216655-002	OPIPZA	5MG	FILM / ORAL	RLD	2024-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216655-003	OPIPZA	10MG	FILM / ORAL	RLD, RS	2024-07-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216655-001	OPIPZA	2MG	FILM / ORAL	RLD	2024-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216655-002	OPIPZA	5MG	FILM / ORAL	RLD	2024-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216655-003	OPIPZA	10MG	FILM / ORAL	RLD, RS	2024-07-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216655-001	OPIPZA	2MG	FILM / ORAL	RLD	2024-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216655-002	OPIPZA	5MG	FILM / ORAL	RLD	2024-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216655-003	OPIPZA	10MG	FILM / ORAL	RLD, RS	2024-07-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216655-001	OPIPZA	2MG	FILM / ORAL	RLD	2024-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216655-002	OPIPZA	5MG	FILM / ORAL	RLD	2024-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216655-003	OPIPZA	10MG	FILM / ORAL	RLD, RS	2024-07-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216655-001	OPIPZA	2MG	FILM / ORAL	RLD	2024-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216655-002	OPIPZA	5MG	FILM / ORAL	RLD	2024-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216655-003	OPIPZA	10MG	FILM / ORAL	RLD, RS	2024-07-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216655-001	OPIPZA	2MG	FILM / ORAL	RLD	2024-07-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216655-002	OPIPZA	5MG	FILM / ORAL	RLD	2024-07-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216655-003	OPIPZA	10MG	FILM / ORAL	RLD, RS	2024-07-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216655-001	OPIPZA	2MG	FILM / ORAL	RLD	2024-07-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216655-002	OPIPZA	5MG	FILM / ORAL	RLD	2024-07-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216655-003	OPIPZA	10MG	FILM / ORAL	RLD, RS	2024-07-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216655-001	OPIPZA	2MG	FILM / ORAL	RLD	2024-07-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216655-002	OPIPZA	5MG	FILM / ORAL	RLD	2024-07-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216655-003	OPIPZA	10MG	FILM / ORAL	RLD, RS	2024-07-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216655-001	OPIPZA	2MG	FILM / ORAL	RLD	2024-07-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216655-002	OPIPZA	5MG	FILM / ORAL	RLD	2024-07-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216655-003	OPIPZA	10MG	FILM / ORAL	RLD, RS	2024-07-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216655-001	OPIPZA	2MG	FILM / ORAL	RLD	2024-07-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216655-002	OPIPZA	5MG	FILM / ORAL	RLD	2024-07-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216655-003	OPIPZA	10MG	FILM / ORAL	RLD, RS	2024-07-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216655-001	OPIPZA	2MG	FILM / ORAL	RLD	2024-07-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216655-002	OPIPZA	5MG	FILM / ORAL	RLD	2024-07-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216655-003	OPIPZA	10MG	FILM / ORAL	RLD, RS	2024-07-22	`79d66fd596c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216655-001	OPIPZA	2MG	FILM / ORAL	RLD	2024-07-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216655-002	OPIPZA	5MG	FILM / ORAL	RLD	2024-07-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216655-003	OPIPZA	10MG	FILM / ORAL	RLD, RS	2024-07-22	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N216655-001	11331315	2040-11-03	Drug product	2024-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216655-001	11701352	2041-12-15	Drug product	2024-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216655-002	11331315	2040-11-03	Drug product	2024-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216655-002	11701352	2041-12-15	Drug product	2024-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216655-003	11331315	2040-11-03	Drug product	2024-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216655-003	11701352	2041-12-15	Drug product	2024-11-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216655-001	11331315	2040-11-03	Drug product	2024-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216655-001	11701352	2041-12-15	Drug product	2024-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216655-002	11331315	2040-11-03	Drug product	2024-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216655-002	11701352	2041-12-15	Drug product	2024-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216655-003	11331315	2040-11-03	Drug product	2024-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216655-003	11701352	2041-12-15	Drug product	2024-11-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216655-001	11331315	2040-11-03	Drug product	2024-11-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216655-001	11701352	2041-12-15	Drug product	2024-11-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216655-002	11331315	2040-11-03	Drug product	2024-11-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216655-002	11701352	2041-12-15	Drug product	2024-11-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216655-003	11331315	2040-11-03	Drug product	2024-11-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216655-003	11701352	2041-12-15	Drug product	2024-11-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216655-001	11331315	2040-11-03	Drug product	2024-11-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216655-001	11701352	2041-12-15	Drug product	2024-11-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216655-002	11331315	2040-11-03	Drug product	2024-11-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216655-002	11701352	2041-12-15	Drug product	2024-11-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216655-003	11331315	2040-11-03	Drug product	2024-11-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216655-003	11701352	2041-12-15	Drug product	2024-11-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216655-001	11331315	2040-11-03	Drug product	2024-11-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216655-001	11701352	2041-12-15	Drug product	2024-11-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216655-002	11331315	2040-11-03	Drug product	2024-11-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216655-002	11701352	2041-12-15	Drug product	2024-11-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216655-003	11331315	2040-11-03	Drug product	2024-11-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216655-003	11701352	2041-12-15	Drug product	2024-11-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216655-001	11331315	2040-11-03	Drug product	2024-11-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216655-001	11701352	2041-12-15	Drug product	2024-11-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216655-002	11331315	2040-11-03	Drug product	2024-11-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216655-002	11701352	2041-12-15	Drug product	2024-11-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216655-003	11331315	2040-11-03	Drug product	2024-11-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216655-003	11701352	2041-12-15	Drug product	2024-11-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216655-001	11331315	2040-11-03	Drug product	2024-11-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216655-001	11701352	2041-12-15	Drug product	2024-11-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216655-002	11331315	2040-11-03	Drug product	2024-11-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216655-002	11701352	2041-12-15	Drug product	2024-11-12	`03ed91905a0d…`

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
OPIPZA	ARIPIPRAZOLE	Carwin Pharmaceutical Associates, LLC	b47ede68-8942-4432-af7e-57afc14b2ba4	2025-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 216655 application number: NDA216655

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81689	SUPPL	2025-03-24
81688	SUPPL	2025-03-24
81680	SUPPL	2025-03-24
80823	ORIG	2025-01-08
79172	ORIG	2024-07-24
79157	ORIG	2024-07-23