Application 205064

Type: ANDA
Sponsor: HETERO LABS LTD V

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 43.

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
A205064-001	ARIPIPRAZOLE	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28
A205064-002	ARIPIPRAZOLE	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28
A205064-003	ARIPIPRAZOLE	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28
A205064-004	ARIPIPRAZOLE	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28
A205064-005	ARIPIPRAZOLE	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28
A205064-006	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
A205064-001	AB
A205064-002	AB
A205064-003	AB
A205064-004	AB
A205064-005	AB
A205064-006	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 · 258 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
2026-09-14 22:38:34	2026-08	A205064-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205064-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205064-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205064-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205064-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205064-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205064-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205064-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205064-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205064-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205064-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205064-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205064-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205064-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205064-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205064-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205064-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205064-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205064-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205064-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205064-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205064-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205064-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205064-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205064-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205064-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205064-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205064-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205064-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205064-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205064-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205064-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205064-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205064-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205064-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205064-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205064-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205064-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205064-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205064-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A205064-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205064-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205064-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205064-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205064-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205064-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205064-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205064-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205064-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205064-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205064-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205064-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205064-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205064-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205064-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205064-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205064-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205064-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205064-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205064-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205064-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205064-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205064-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205064-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205064-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205064-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205064-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205064-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205064-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205064-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205064-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205064-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205064-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205064-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205064-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205064-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205064-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205064-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205064-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205064-004	AB	1	`b8a1b40f171c…`

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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aripiprazole	ARIPIPRAZOLE	NuCare Pharmaceuticals, Inc.	414b7fd2-6a63-af39-e063-6394a90a00b8	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	PD-Rx Pharmaceuticals, Inc.	0cf6655e-d59a-4ebd-9698-195cad2adbd5	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	AvPAK	7df4c83e-13d8-25b1-57eb-08d26ba03565	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	NuCare Pharmaceuticals, Inc.	3cf72cc6-ae43-bfd5-e063-6294a90a18b0	2025-08-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	American Health Packaging	80e079f0-faf5-4c0c-b1a8-9bc3cc2cde00	2025-08-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	NuCare Pharmaceuticals,Inc.	3726d102-dd9f-645e-e063-6294a90aeb9e	2025-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	Direct_Rx	f823bc23-27f3-2397-e053-6294a90a365a	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	A-S Medication Solutions	89c2cddc-2ae3-4505-adf9-018542c713bf	2024-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	3c0109f6-0549-4f91-a259-d9d6d7329b91	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064 ndc (product): 71335-1893
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	6b0c3767-d397-4c7f-b229-083620d9ae6b	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064 ndc (product): 71335-1892
Aripiprazole	ARIPIPRAZOLE	Camber Pharmaceuticals, Inc.	2d8d574b-fbf4-4d2c-a37c-25556ecbf1aa	2024-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	NorthStar RxLLC	f87dbfe4-5417-47c9-a97f-d246cfc10023	2023-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	XLCare Pharmaceuticals, Inc.	0a6fa113-6bb2-4f88-af07-ce0914c98ff2	2023-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064 ndc (product): 72865-183 ndc (product): 72865-180 ndc (product): 72865-182 ndc (product): 72865-184 ndc (product): 72865-181 ndc (product): 72865-185
Aripiprazole	ARIPIPRAZOLE	XLCare Pharmaceuticals, Inc.	b284b294-40a0-4ccd-b7b7-b61267cd4e76	2023-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064 ndc (product): 72865-155 ndc (product): 72865-157 ndc (product): 72865-158 ndc (product): 72865-154 ndc (product): 72865-153 ndc (product): 72865-156
Aripiprazole	ARIPIPRAZOLE	Exelan Pharmaceuticals, Inc.	705190bf-9f9d-4183-a56b-4eeafeacde59	2018-12-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064 ndc (product): 76282-045 ndc (product): 76282-049 ndc (product): 76282-044 ndc (product): 76282-048 ndc (product): 76282-046 ndc (product): 76282-047
ARIPIPRAZOLE	ARIPIPRAZOLE	Camber Pharmaceuticals, Inc.	3718e585-06b9-40fd-a3eb-18b6497a4235	2017-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 103 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70518-2163	Aripiprazole	Aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2163	Aripiprazole	Aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2164	Aripiprazole	Aripiprazole	REMEDYREPACK INC.	ANDA	Current
71335-1892	Aripiprazole	Aripiprazole	Bryant Ranch Prepack	ANDA	Current
71335-1893	Aripiprazole	Aripiprazole	Bryant Ranch Prepack	ANDA	Current
72865-153	Aripiprazole	Aripiprazole	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-154	Aripiprazole	Aripiprazole	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-155	Aripiprazole	Aripiprazole	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-156	Aripiprazole	Aripiprazole	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-157	Aripiprazole	Aripiprazole	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-158	Aripiprazole	Aripiprazole	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-180	Aripiprazole	Aripiprazole	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-181	Aripiprazole	Aripiprazole	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-182	Aripiprazole	Aripiprazole	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-183	Aripiprazole	Aripiprazole	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-184	Aripiprazole	Aripiprazole	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-185	Aripiprazole	Aripiprazole	XLCare Pharmaceuticals, Inc.	ANDA	Current
76282-044	Aripiprazole	Aripiprazole	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-045	Aripiprazole	Aripiprazole	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-046	Aripiprazole	Aripiprazole	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-047	Aripiprazole	Aripiprazole	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-048	Aripiprazole	Aripiprazole	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-049	Aripiprazole	Aripiprazole	Exelan Pharmaceuticals, Inc.	ANDA	Current