Application 090165

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ARIPIPRAZOLE	ARIPIPRAZOLE	TABLET, ORALLY DISINTEGRATING;ORAL	10MG	No	No
002	ARIPIPRAZOLE	ARIPIPRAZOLE	TABLET, ORALLY DISINTEGRATING;ORAL	15MG	No	No
003	ARIPIPRAZOLE	ARIPIPRAZOLE	TABLET, ORALLY DISINTEGRATING;ORAL	20MG	No	No
004	ARIPIPRAZOLE	ARIPIPRAZOLE	TABLET, ORALLY DISINTEGRATING;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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090165-001	ARIPIPRAZOLE	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28
A090165-002	ARIPIPRAZOLE	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28
A090165-003	ARIPIPRAZOLE	ARIPIPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28
A090165-004	ARIPIPRAZOLE	ARIPIPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A090165-001	AB
A090165-002	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 5 · 164 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	A090165-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090165-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090165-003	ARIPIPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090165-004	ARIPIPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090165-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090165-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090165-003	ARIPIPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090165-004	ARIPIPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090165-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090165-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090165-003	ARIPIPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090165-004	ARIPIPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090165-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090165-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090165-003	ARIPIPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090165-004	ARIPIPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090165-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090165-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090165-003	ARIPIPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090165-004	ARIPIPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090165-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090165-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090165-003	ARIPIPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090165-004	ARIPIPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090165-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090165-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090165-003	ARIPIPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090165-004	ARIPIPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090165-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090165-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090165-003	ARIPIPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090165-004	ARIPIPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090165-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090165-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090165-003	ARIPIPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090165-004	ARIPIPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090165-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090165-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090165-003	ARIPIPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090165-004	ARIPIPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A090165-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090165-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090165-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090165-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090165-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090165-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090165-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090165-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090165-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090165-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090165-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090165-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090165-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090165-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090165-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090165-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090165-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090165-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090165-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090165-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090165-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090165-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090165-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090165-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090165-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090165-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090165-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090165-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090165-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090165-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090165-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090165-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090165-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090165-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090165-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090165-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090165-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090165-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090165-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090165-002	AB	1	`782e0a99824c…`

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	Viona Pharmaceuticals Inc.	73c5e380-b7b1-4362-a827-71881574ff48	2025-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090165 application number: ANDA090165 ndc (product): 72578-107 ndc (product): 72578-106
Aripiprazole	ARIPIPRAZOLE	SQUARE PHARMACEUTICALS LIMITED	0f9b1fd8-a648-45c9-8655-14de07439f34	2023-07-02		Exact identifier application applno (ANDA): 090165 application number: ANDA090165 ndc (product): 76483-102 ndc (product): 76483-103 ndc (product): 76483-100 ndc (product): 76483-101

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68382-087	aripiprazole	aripiprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-087	aripiprazole	aripiprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-087	aripiprazole	aripiprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-088	aripiprazole	aripiprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-088	aripiprazole	aripiprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-088	aripiprazole	aripiprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-089	aripiprazole	aripiprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-089	aripiprazole	aripiprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-089	aripiprazole	aripiprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-090	aripiprazole	aripiprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-090	aripiprazole	aripiprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-090	aripiprazole	aripiprazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1432	aripiprazole	aripiprazole	Cadila Healthcare Limited	ANDA	Current
70771-1432	aripiprazole	aripiprazole	Cadila Healthcare Limited	ANDA	Current
70771-1432	aripiprazole	aripiprazole	Cadila Healthcare Limited	ANDA	Current
70771-1433	aripiprazole	aripiprazole	Cadila Healthcare Limited	ANDA	Current
70771-1433	aripiprazole	aripiprazole	Cadila Healthcare Limited	ANDA	Current
70771-1433	aripiprazole	aripiprazole	Cadila Healthcare Limited	ANDA	Current
70771-1434	aripiprazole	aripiprazole	Cadila Healthcare Limited	ANDA	Current
70771-1434	aripiprazole	aripiprazole	Cadila Healthcare Limited	ANDA	Current
70771-1434	aripiprazole	aripiprazole	Cadila Healthcare Limited	ANDA	Current
70771-1435	aripiprazole	aripiprazole	Cadila Healthcare Limited	ANDA	Current
70771-1435	aripiprazole	aripiprazole	Cadila Healthcare Limited	ANDA	Current
70771-1435	aripiprazole	aripiprazole	Cadila Healthcare Limited	ANDA	Current
72578-106	Aripiprazole	Aripiprazole	Viona Pharmaceuticals Inc.	ANDA	Current
72578-106	Aripiprazole	Aripiprazole	Viona Pharmaceuticals Inc.	ANDA	Current
72578-106	Aripiprazole	Aripiprazole	Viona Pharmaceuticals Inc.	ANDA	Current
72578-107	Aripiprazole	Aripiprazole	Viona Pharmaceuticals Inc.	ANDA	Current
72578-107	Aripiprazole	Aripiprazole	Viona Pharmaceuticals Inc.	ANDA	Current
72578-107	Aripiprazole	Aripiprazole	Viona Pharmaceuticals Inc.	ANDA	Current
76483-100	Aripiprazole	Aripiprazole	SQUARE PHARMACEUTICALS LIMITED	ANDA	Current
76483-101	Aripiprazole	Aripiprazole	SQUARE PHARMACEUTICALS LIMITED	ANDA	Current
76483-102	Aripiprazole	Aripiprazole	SQUARE PHARMACEUTICALS LIMITED	ANDA	Current
76483-103	Aripiprazole	Aripiprazole	SQUARE PHARMACEUTICALS LIMITED	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
55411	ORIG	2018-09-07