Application 207105

Type: ANDA
Sponsor: ALKEM LABS 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 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
A207105-001	ARIPIPRAZOLE	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2019-02-21
A207105-002	ARIPIPRAZOLE	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2019-02-21
A207105-003	ARIPIPRAZOLE	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2019-02-21
A207105-004	ARIPIPRAZOLE	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2019-02-21
A207105-005	ARIPIPRAZOLE	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2019-02-21
A207105-006	ARIPIPRAZOLE	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2019-02-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207105-001	AB
A207105-002	AB
A207105-003	AB
A207105-004	AB
A207105-005	AB
A207105-006	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	A207105-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2019-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207105-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2019-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207105-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2019-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207105-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2019-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207105-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2019-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207105-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2019-02-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207105-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2019-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207105-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2019-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207105-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2019-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207105-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2019-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207105-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2019-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207105-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2019-02-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207105-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2019-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207105-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2019-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207105-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2019-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207105-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2019-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207105-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2019-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207105-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2019-02-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207105-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2019-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207105-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2019-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207105-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2019-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207105-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2019-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207105-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2019-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207105-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2019-02-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207105-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2019-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207105-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2019-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207105-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2019-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207105-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2019-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207105-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2019-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207105-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2019-02-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207105-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2019-02-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207105-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2019-02-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207105-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2019-02-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207105-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2019-02-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207105-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2019-02-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207105-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2019-02-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207105-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2019-02-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207105-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2019-02-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207105-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2019-02-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207105-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2019-02-21	`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	A207105-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207105-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207105-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207105-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207105-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207105-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207105-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207105-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207105-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207105-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207105-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207105-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207105-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207105-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207105-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207105-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207105-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207105-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207105-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207105-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207105-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207105-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207105-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207105-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207105-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207105-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207105-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207105-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207105-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207105-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207105-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207105-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207105-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207105-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207105-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207105-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207105-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207105-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207105-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207105-004	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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	1d593ada-256d-4dec-9a26-2a6a67d97205	2026-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	bc3fde41-2f24-44e2-815d-15fe55bd68b3	2026-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	506fa28f-6f98-4632-bce8-72a9cb507c90	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	f713c38e-cc49-4243-96b9-32d5dbbcf9cb	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	55f3a705-9412-0f88-e063-6294a90a2b53	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	55f446b0-caa2-aca8-e063-6294a90af441	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	52bbfc8f-fa17-839e-e063-6394a90a6316	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	50214c47-2ea3-b373-e063-6394a90aad23	2026-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	6f580e75-61ab-4c7b-bb3f-f027a9603f84	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	433cdc7d-465a-4ad4-bd84-cabd37e15f51	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	ff8dc838-ca1a-49d3-8938-5ae645574a75	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	1e8d889e-126b-4627-a2cc-34f2d35a5d67	2026-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	1ef9e44f-5672-47c2-97e9-286e1b84417d	2026-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105 ndc (product): 71335-1935
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	4bda6f17-d87c-4009-b329-99275c56106f	2026-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	fb40b669-4e37-4087-8fb1-3ac140543602	2026-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	A-S Medication Solutions	554db933-aa80-4685-bcd5-58c84571c19c	2026-01-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	Ascend Laboratories, LLC	c7040fef-96a7-4429-9a8e-ec3ab17a8019	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	Direct_Rx	facdb9a9-612f-e59a-e053-6394a90a1fa7	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	Direct_Rx	fcea91c3-e428-8991-e053-6394a90a099d	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	Preferred Pharmaceuticals Inc.	34127431-6ad7-402f-bc22-1429c55d921c	2025-01-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105

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 · 83 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71335-1935	Aripiprazole	Aripiprazole	Bryant Ranch Prepack	ANDA	Current
71335-1980	Aripiprazole	Aripiprazole	Bryant Ranch Prepack	ANDA	Current
71335-1980	Aripiprazole	Aripiprazole	Bryant Ranch Prepack	ANDA	Current