Application 201519

Type: ANDA
Sponsor: TORRENT

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 42.

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
A201519-001	ARIPIPRAZOLE	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28
A201519-002	ARIPIPRAZOLE	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28
A201519-003	ARIPIPRAZOLE	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28
A201519-004	ARIPIPRAZOLE	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28
A201519-005	ARIPIPRAZOLE	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28
A201519-006	ARIPIPRAZOLE	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201519-001	AB
A201519-002	AB
A201519-003	AB
A201519-004	AB
A201519-005	AB
A201519-006	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 · 252 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
2026-08-18 06:07:40	2026-07	A201519-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201519-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201519-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201519-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201519-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201519-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201519-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201519-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201519-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201519-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201519-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201519-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201519-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201519-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201519-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201519-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201519-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201519-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201519-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201519-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201519-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201519-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201519-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201519-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201519-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201519-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201519-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201519-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201519-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201519-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201519-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201519-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201519-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201519-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201519-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201519-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201519-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201519-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201519-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201519-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 252 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A201519-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201519-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201519-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201519-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201519-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201519-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201519-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201519-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201519-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201519-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201519-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201519-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201519-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201519-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201519-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201519-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201519-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201519-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201519-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201519-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201519-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201519-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201519-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201519-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201519-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201519-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201519-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201519-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201519-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201519-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201519-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201519-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201519-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201519-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201519-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201519-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201519-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201519-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201519-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201519-004	AB	1	`03ed91905a0d…`

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	1ad7d167-1235-4c5c-8159-da8972240ede	2026-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201519 application number: ANDA201519 ndc (product): 70518-2584
aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	9b695d4b-3794-4b89-8575-6feb83697ccc	2026-05-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201519 application number: ANDA201519 ndc (product): 70518-2643
aripiprazole	ARIPIPRAZOLE	Major Pharmaceuticals	969c17aa-6abc-413c-8561-f1ad8fdde3e5	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201519 application number: ANDA201519
aripiprazole	ARIPIPRAZOLE	Proficient Rx LP	2c2b0172-b186-4be4-a002-4a26adf120c6	2025-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201519 application number: ANDA201519
aripiprazole	ARIPIPRAZOLE	Proficient Rx LP	a3c0be94-c6c0-47e2-892f-c51f100fb3a3	2025-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201519 application number: ANDA201519
aripiprazole	ARIPIPRAZOLE	ST. MARY'S MEDICAL PARK PHARMACY	35a86989-862e-b0bb-e063-6394a90a7ec1	2025-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201519 application number: ANDA201519
aripiprazole	ARIPIPRAZOLE	Torrent Pharmaceuticals Limited	3988e66f-339c-451e-9f8a-9d0c0a2a381b	2025-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201519 application number: ANDA201519
Aripiprazole	ARIPIPRAZOLE	Direct_Rx	f81d9b82-5879-3c0a-e053-6294a90ac23e	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201519 application number: ANDA201519
aripiprazole	ARIPIPRAZOLE	Preferred Pharmaceuticals Inc.	faa3032b-d9a1-45dd-88be-abb432223f13	2025-01-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201519 application number: ANDA201519
aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	e7b6a156-8001-441c-bfd3-bf8987a339e8	2024-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201519 application number: ANDA201519 ndc (product): 71335-0412
aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	b62837db-1949-4dba-9e2f-714a9f136f5a	2024-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201519 application number: ANDA201519
aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	d130836c-5f1c-4779-ac6c-6350752dc015	2024-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201519 application number: ANDA201519
aripiprazole	ARIPIPRAZOLE	A-S Medication Solutions	ab3973f3-3db8-4db2-8258-1b21af7b6380	2024-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201519 application number: ANDA201519

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 127 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70518-1129	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-1263	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-1263	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-1263	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-1263	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-1263	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-1295	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-1295	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-1295	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-1303	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-1303	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-1303	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-1303	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-1303	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-1317	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-1317	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-1317	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-1327	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-1327	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-1327	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2536	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2536	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2536	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2557	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2557	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2557	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2580	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2580	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2580	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2584	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2584	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2584	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2584	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2584	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2643	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2643	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2643	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2643	aripiprazole	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70934-001	aripiprazole	aripiprazole	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-002	aripiprazole	aripiprazole	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-0412	aripiprazole	aripiprazole	Bryant Ranch Prepack	ANDA	Current
71335-0412	aripiprazole	aripiprazole	Bryant Ranch Prepack	ANDA	Current
71335-0412	aripiprazole	aripiprazole	Bryant Ranch Prepack	ANDA	Current
71335-0412	aripiprazole	aripiprazole	Bryant Ranch Prepack	ANDA	Current
71335-0895	aripiprazole	aripiprazole	Bryant Ranch Prepack	ANDA	Current
71335-0895	aripiprazole	aripiprazole	Bryant Ranch Prepack	ANDA	Current
71335-0895	aripiprazole	aripiprazole	Bryant Ranch Prepack	ANDA	Current