Application 206251

Type: ANDA
Sponsor: ACCORD 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
A206251-001	ARIPIPRAZOLE	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-12-07
A206251-002	ARIPIPRAZOLE	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-12-07
A206251-003	ARIPIPRAZOLE	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-12-07
A206251-004	ARIPIPRAZOLE	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-12-07
A206251-005	ARIPIPRAZOLE	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-12-07
A206251-006	ARIPIPRAZOLE	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-12-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206251-001	AB
A206251-002	AB
A206251-003	AB
A206251-004	AB
A206251-005	AB
A206251-006	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	A206251-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206251-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206251-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206251-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206251-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206251-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206251-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206251-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206251-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206251-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206251-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206251-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206251-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206251-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206251-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206251-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206251-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206251-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206251-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206251-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206251-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206251-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206251-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206251-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206251-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206251-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206251-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206251-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206251-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206251-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206251-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206251-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206251-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206251-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206251-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206251-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206251-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206251-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206251-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206251-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-12-07	`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	A206251-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206251-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206251-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206251-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206251-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206251-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206251-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206251-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206251-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206251-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206251-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206251-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206251-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206251-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206251-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206251-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206251-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206251-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206251-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206251-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206251-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206251-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206251-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206251-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206251-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206251-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206251-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206251-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206251-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206251-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206251-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206251-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206251-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206251-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206251-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206251-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206251-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206251-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206251-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206251-004	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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	85cc7d25-414b-4b6f-a03a-48af908a16a1	2025-10-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206251 application number: ANDA206251 ndc (product): 16729-281 ndc (product): 16729-278 ndc (product): 16729-283 ndc (product): 16729-279 ndc (product): 16729-282 ndc (product): 16729-280
ARIPIPRAZOLE	ARIPIPRAZOLE	A-S Medication Solutions	aaf7dc7e-04f3-442b-86d7-5f54d17d102c	2022-09-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206251 application number: ANDA206251

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16729-278	ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	ANDA	Current
16729-278	ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	ANDA	Current
16729-278	ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	ANDA	Current
16729-278	ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	ANDA	Current
16729-278	ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	ANDA	Current
16729-279	ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	ANDA	Current
16729-279	ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	ANDA	Current
16729-279	ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	ANDA	Current
16729-279	ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	ANDA	Current
16729-279	ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	ANDA	Current
16729-280	ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	ANDA	Current
16729-280	ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	ANDA	Current
16729-280	ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	ANDA	Current
16729-280	ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	ANDA	Current
16729-280	ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	ANDA	Current
16729-281	ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	ANDA	Current
16729-281	ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	ANDA	Current
16729-281	ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	ANDA	Current
16729-281	ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	ANDA	Current
16729-281	ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	ANDA	Current
16729-282	ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	ANDA	Current
16729-282	ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	ANDA	Current
16729-282	ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	ANDA	Current
16729-282	ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	ANDA	Current
16729-282	ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	ANDA	Current
16729-283	ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	ANDA	Current
16729-283	ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	ANDA	Current
16729-283	ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	ANDA	Current
16729-283	ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	ANDA	Current
16729-283	ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	ANDA	Current
50090-3070	ARIPIPRAZOLE	ARIPIPRAZOLE	A-S Medication Solutions	ANDA	Current
50090-3073	ARIPIPRAZOLE	ARIPIPRAZOLE	A-S Medication Solutions	ANDA	Current
50090-3073	ARIPIPRAZOLE	ARIPIPRAZOLE	A-S Medication Solutions	ANDA	Current
50090-3941	ARIPIPRAZOLE	ARIPIPRAZOLE	A-S Medication Solutions	ANDA	Current
50090-3941	ARIPIPRAZOLE	ARIPIPRAZOLE	A-S Medication Solutions	ANDA	Current
50090-4160	ARIPIPRAZOLE	ARIPIPRAZOLE	A-S Medication Solutions	ANDA	Current
50090-4160	ARIPIPRAZOLE	ARIPIPRAZOLE	A-S Medication Solutions	ANDA	Current
50090-4160	ARIPIPRAZOLE	ARIPIPRAZOLE	A-S Medication Solutions	ANDA	Current
50090-4800	ARIPIPRAZOLE	ARIPIPRAZOLE	A-S Medication Solutions	ANDA	Current
50090-4800	ARIPIPRAZOLE	ARIPIPRAZOLE	A-S Medication Solutions	ANDA	Current
70518-1155	ARIPIPRAZOLE	ARIPIPRAZOLE	REMEDYREPACK INC.	ANDA	Current
70518-1155	ARIPIPRAZOLE	ARIPIPRAZOLE	REMEDYREPACK INC.	ANDA	Current
70518-2921	ARIPIPRAZOLE	ARIPIPRAZOLE	REMEDYREPACK INC.	ANDA	Current
70518-2921	ARIPIPRAZOLE	ARIPIPRAZOLE	REMEDYREPACK INC.	ANDA	Current
70518-3011	ARIPIPRAZOLE	ARIPIPRAZOLE	REMEDYREPACK INC.	ANDA	Current
70934-662	ARIPIPRAZOLE	ARIPIPRAZOLE	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
46107	ORIG	2016-12-09