Application 202102

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ARIPIPRAZOLE	ARIPIPRAZOLE	TABLET, ORALLY DISINTEGRATING;ORAL	10MG	No	Yes
002	ARIPIPRAZOLE	ARIPIPRAZOLE	TABLET, ORALLY DISINTEGRATING;ORAL	15MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202102-001	ARIPIPRAZOLE	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2015-04-28
A202102-002	ARIPIPRAZOLE	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-04-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202102-001	AB
A202102-002	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202102-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202102-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202102-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202102-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202102-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202102-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202102-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202102-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202102-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2015-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202102-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202102-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2015-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202102-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202102-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2015-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202102-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202102-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2015-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202102-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202102-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2015-04-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202102-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202102-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2015-04-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202102-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-04-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202102-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2015-04-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202102-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-04-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202102-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2015-04-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202102-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-04-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202102-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2015-04-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202102-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-04-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202102-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2015-04-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202102-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-04-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202102-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2015-04-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202102-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-04-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202102-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2015-04-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202102-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-04-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202102-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2015-04-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202102-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-04-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202102-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2015-04-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202102-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-04-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202102-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2015-04-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202102-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-04-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202102-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2015-04-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202102-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-04-28	`782e0a99824c…`

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	A202102-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202102-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202102-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202102-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202102-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202102-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202102-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202102-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202102-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202102-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202102-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202102-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202102-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202102-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202102-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202102-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202102-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202102-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202102-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202102-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202102-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202102-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202102-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202102-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202102-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202102-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202102-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202102-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202102-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202102-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202102-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202102-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202102-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202102-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202102-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202102-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202102-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202102-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202102-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202102-002	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	Alembic Pharmaceuticals Inc.	de2dc5fd-ecb4-4445-9cfb-10e64fe3269d	2025-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202102 application number: ANDA202102 ndc (product): 62332-103 ndc (product): 62332-104
Aripiprazole	ARIPIPRAZOLE	Alembic Pharmaceuticals Limited	4f1691a8-724e-430d-9bab-27b59ef9bd4e	2023-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202102 application number: ANDA202102 ndc (product): 46708-260 ndc (product): 46708-261

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13811-692	Aripiprazole	Aripiprazole	Trigen Laboratories, LLC	ANDA	Current
13811-693	Aripiprazole	Aripiprazole	Trigen Laboratories, LLC	ANDA	Current
46708-260	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Limited	ANDA	Current
46708-260	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Limited	ANDA	Current
46708-261	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Limited	ANDA	Current
46708-261	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Limited	ANDA	Current
62332-103	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-103	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-103	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-103	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-103	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-103	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-104	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-104	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-104	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-104	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-104	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-104	Aripiprazole	Aripiprazole	Alembic Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32179	ORIG	2015-04-29
19060	ORIG	2015-04-29