Application 202683

Type: ANDA
Sponsor: ORCHID HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ARIPIPRAZOLE	ARIPIPRAZOLE	TABLET;ORAL	2MG	No	No
002	ARIPIPRAZOLE	ARIPIPRAZOLE	TABLET;ORAL	5MG	No	No
003	ARIPIPRAZOLE	ARIPIPRAZOLE	TABLET;ORAL	10MG	No	No
004	ARIPIPRAZOLE	ARIPIPRAZOLE	TABLET;ORAL	15MG	No	No
005	ARIPIPRAZOLE	ARIPIPRAZOLE	TABLET;ORAL	20MG	No	No
006	ARIPIPRAZOLE	ARIPIPRAZOLE	TABLET;ORAL	30MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202683-001	ARIPIPRAZOLE	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2017-05-23
A202683-002	ARIPIPRAZOLE	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2017-05-23
A202683-003	ARIPIPRAZOLE	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2017-05-23
A202683-004	ARIPIPRAZOLE	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2017-05-23
A202683-005	ARIPIPRAZOLE	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2017-05-23
A202683-006	ARIPIPRAZOLE	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2017-05-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A202683-001	AB
A202683-002	AB
A202683-003	AB
A202683-004	AB
A202683-005	AB
A202683-006	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 7 · 246 observed 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
2026-02-19 14:30 UTC	2026-02	A202683-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2017-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202683-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2017-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202683-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2017-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202683-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2017-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202683-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2017-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202683-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2017-05-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202683-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2017-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202683-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2017-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202683-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2017-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202683-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2017-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202683-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2017-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202683-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2017-05-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202683-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2017-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202683-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2017-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202683-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2017-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202683-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2017-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202683-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2017-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202683-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2017-05-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202683-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2017-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202683-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2017-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202683-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2017-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202683-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2017-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202683-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2017-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202683-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2017-05-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202683-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2017-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202683-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2017-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202683-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2017-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202683-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2017-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202683-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2017-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202683-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2017-05-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202683-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2017-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202683-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2017-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202683-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2017-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202683-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2017-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202683-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2017-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202683-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2017-05-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202683-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2017-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202683-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2017-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202683-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2017-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202683-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2017-05-23	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 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	A202683-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202683-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202683-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202683-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202683-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202683-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202683-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202683-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202683-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202683-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202683-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202683-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202683-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202683-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202683-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202683-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202683-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202683-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202683-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202683-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202683-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202683-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202683-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202683-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202683-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202683-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202683-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202683-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202683-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202683-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202683-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202683-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202683-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202683-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202683-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202683-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202683-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202683-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202683-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202683-004	AB	1	`2680178bc6a6…`

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 6 · 118 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	bc3fde41-2f24-44e2-815d-15fe55bd68b3	2026-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	506fa28f-6f98-4632-bce8-72a9cb507c90	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	f713c38e-cc49-4243-96b9-32d5dbbcf9cb	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	1ad7d167-1235-4c5c-8159-da8972240ede	2026-07-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	119e3387-39a2-4fe5-904b-c2d008425c0a	2026-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE ORALLY DISINTEGRATING	Dr. Reddy's Laboratories Inc	394ea4a4-3991-4f98-b38f-56e9335d66b3	2026-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	99747897-22fe-4bee-9942-6349c0c8f6b0	2026-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE ORAL	ATLANTIC BIOLOGICALS CORP.	042b725c-1c17-4cfb-80b2-c841226d795e	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	56439ef6-a07e-34c9-e063-6294a90a77c3	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	55f3a705-9412-0f88-e063-6294a90a2b53	2026-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	55f446b0-caa2-aca8-e063-6294a90af441	2026-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	a1191a90-eb83-4a59-948c-b9774d2c83a5	2026-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	69af5199-f872-4298-8d09-035e2127d3d4	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Unit Dose Solutions, Inc.	535f4fbd-b6a7-7611-e063-6294a90a5c43	2026-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	52cc86ba-2c4f-1aba-e063-6294a90a844e	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	52bbfc8f-fa17-839e-e063-6394a90a6316	2026-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Major Pharmaceuticals	573c6bb6-941f-4413-8c23-826025385864	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	9b695d4b-3794-4b89-8575-6feb83697ccc	2026-05-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	c092a736-16e2-4dd0-8769-cb766a62f4d9	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	512874e6-6d00-2623-e063-6394a90aa4bc	2026-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE