Application 206174

Type: ANDA
Sponsor: AJANTA PHARMA LTD

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
A206174-001	ARIPIPRAZOLE	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-09-12
A206174-002	ARIPIPRAZOLE	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-09-12
A206174-003	ARIPIPRAZOLE	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-09-12
A206174-004	ARIPIPRAZOLE	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-09-12
A206174-005	ARIPIPRAZOLE	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-09-12
A206174-006	ARIPIPRAZOLE	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-09-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206174-001	AB
A206174-002	AB
A206174-003	AB
A206174-004	AB
A206174-005	AB
A206174-006	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	A206174-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206174-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206174-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206174-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206174-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206174-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-09-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206174-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206174-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206174-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206174-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206174-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206174-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-09-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206174-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206174-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206174-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206174-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206174-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206174-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-09-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206174-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206174-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206174-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206174-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206174-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206174-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-09-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206174-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206174-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206174-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206174-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206174-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206174-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-09-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206174-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206174-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206174-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206174-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206174-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206174-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-09-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206174-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206174-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206174-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206174-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-09-12	`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	A206174-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206174-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206174-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206174-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206174-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206174-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206174-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206174-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206174-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206174-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206174-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206174-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206174-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206174-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206174-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206174-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206174-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206174-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206174-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206174-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206174-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206174-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206174-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206174-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206174-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206174-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206174-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206174-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206174-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206174-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206174-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206174-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206174-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206174-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206174-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206174-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206174-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206174-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206174-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206174-004	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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	69af5199-f872-4298-8d09-035e2127d3d4	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206174 application number: ANDA206174 ndc (product): 71335-1515
Aripiprazole	ARIPIPRAZOLE	Unit Dose Solutions, Inc.	535f4fbd-b6a7-7611-e063-6294a90a5c43	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206174 application number: ANDA206174
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	c092a736-16e2-4dd0-8769-cb766a62f4d9	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206174 application number: ANDA206174 ndc (product): 71335-1682
Aripiprazole	ARIPIPRAZOLE	Preferred Pharmaceuticals, Inc.	36fb0c13-dfae-46ac-bb71-0b53fe5649f4	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206174 application number: ANDA206174 ndc (product): 68788-7749
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	2bc00231-c2e7-4b9d-93a1-fb796fd8d591	2026-02-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206174 application number: ANDA206174 ndc (product): 70518-2736
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	47430dfa-9377-6c31-e063-6394a90a86a9	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206174 application number: ANDA206174
Aripiprazole	ARIPIPRAZOLE	Quallent Pharmaceuticals Health LLC	0e0d42ad-f4c6-4e30-adc2-ab1d122428ec	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206174 application number: ANDA206174
Aripiprazole	ARIPIPRAZOLE	Ajanta Pharma USA Inc.	d0f910b5-adef-4a93-9369-70f1ed541503	2025-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206174 application number: ANDA206174 ndc (product): 27241-056 ndc (product): 27241-054 ndc (product): 27241-052 ndc (product): 27241-053 ndc (product): 27241-055 ndc (product): 27241-051
Aripiprazole	ARIPIPRAZOLE	A-S Medication Solutions	13339e7f-a8b4-430d-b623-47372de98348	2024-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206174 application number: ANDA206174
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	fd2fa4da-2ee9-4965-b1f8-ce1c8b73ba93	2023-11-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206174 application number: ANDA206174 ndc (product): 71335-1513

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 43 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
27241-051	Aripiprazole	Aripiprazole	Ajanta Pharma USA Inc.	ANDA	Current
27241-051	Aripiprazole	Aripiprazole	Ajanta Pharma Limited	ANDA	Current
27241-051	Aripiprazole	Aripiprazole	Ajanta Pharma Limited	ANDA	Current
27241-051	Aripiprazole	Aripiprazole	Ajanta Pharma Limited	ANDA	Current
27241-052	Aripiprazole	Aripiprazole	Ajanta Pharma USA Inc.	ANDA	Current
27241-052	Aripiprazole	Aripiprazole	Ajanta Pharma Limited	ANDA	Current
27241-052	Aripiprazole	Aripiprazole	Ajanta Pharma Limited	ANDA	Current
27241-052	Aripiprazole	Aripiprazole	Ajanta Pharma Limited	ANDA	Current
27241-053	Aripiprazole	Aripiprazole	Ajanta Pharma USA Inc.	ANDA	Current
27241-053	Aripiprazole	Aripiprazole	Ajanta Pharma Limited	ANDA	Current
27241-053	Aripiprazole	Aripiprazole	Ajanta Pharma Limited	ANDA	Current
27241-053	Aripiprazole	Aripiprazole	Ajanta Pharma Limited	ANDA	Current
27241-054	Aripiprazole	Aripiprazole	Ajanta Pharma USA Inc.	ANDA	Current
27241-054	Aripiprazole	Aripiprazole	Ajanta Pharma Limited	ANDA	Current
27241-054	Aripiprazole	Aripiprazole	Ajanta Pharma Limited	ANDA	Current
27241-054	Aripiprazole	Aripiprazole	Ajanta Pharma Limited	ANDA	Current
27241-055	Aripiprazole	Aripiprazole	Ajanta Pharma USA Inc.	ANDA	Current
27241-055	Aripiprazole	Aripiprazole	Ajanta Pharma Limited	ANDA	Current
27241-055	Aripiprazole	Aripiprazole	Ajanta Pharma Limited	ANDA	Current
27241-055	Aripiprazole	Aripiprazole	Ajanta Pharma Limited	ANDA	Current
27241-056	Aripiprazole	Aripiprazole	Ajanta Pharma USA Inc.	ANDA	Current
27241-056	Aripiprazole	Aripiprazole	Ajanta Pharma Limited	ANDA	Current
27241-056	Aripiprazole	Aripiprazole	Ajanta Pharma Limited	ANDA	Current
27241-056	Aripiprazole	Aripiprazole	Ajanta Pharma Limited	ANDA	Current
68788-7749	Aripiprazole	Aripiprazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7749	Aripiprazole	Aripiprazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7749	Aripiprazole	Aripiprazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-1859	Aripiprazole	Aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-1859	Aripiprazole	Aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2736	Aripiprazole	Aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2736	Aripiprazole	Aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2736	Aripiprazole	Aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2736	Aripiprazole	Aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2765	Aripiprazole	Aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2765	Aripiprazole	Aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2950	Aripiprazole	Aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2950	Aripiprazole	Aripiprazole	REMEDYREPACK INC.	ANDA	Current
71335-1513	Aripiprazole	Aripiprazole	Bryant Ranch Prepack	ANDA	Current
71335-1513	Aripiprazole	Aripiprazole	Bryant Ranch Prepack	ANDA	Current
71335-1515	Aripiprazole	Aripiprazole	Bryant Ranch Prepack	ANDA	Current
71335-1515	Aripiprazole	Aripiprazole	Bryant Ranch Prepack	ANDA	Current
71335-1682	Aripiprazole	Aripiprazole	Bryant Ranch Prepack	ANDA	Current
71335-1682	Aripiprazole	Aripiprazole	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
45328	ORIG	2016-09-15