Application 203908

Type: ANDA
Sponsor: AUROBINDO PHARMA 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 1.

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
A203908-001	ARIPIPRAZOLE	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-10-08
A203908-002	ARIPIPRAZOLE	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-10-08
A203908-003	ARIPIPRAZOLE	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-10-08
A203908-004	ARIPIPRAZOLE	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-10-08
A203908-005	ARIPIPRAZOLE	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-10-08
A203908-006	ARIPIPRAZOLE	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-10-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203908-001	AB
A203908-002	AB
A203908-003	AB
A203908-004	AB
A203908-005	AB
A203908-006	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 · 246 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	A203908-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203908-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203908-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203908-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203908-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203908-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203908-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203908-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203908-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203908-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203908-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203908-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203908-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203908-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203908-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203908-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203908-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203908-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-10-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203908-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203908-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203908-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203908-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203908-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203908-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203908-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203908-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203908-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203908-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203908-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203908-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-10-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203908-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203908-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203908-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203908-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203908-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203908-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-10-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203908-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203908-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203908-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203908-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-10-08	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 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	A203908-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203908-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203908-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203908-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203908-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203908-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203908-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203908-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203908-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203908-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203908-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203908-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203908-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203908-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203908-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203908-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203908-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203908-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203908-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203908-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203908-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203908-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203908-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203908-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203908-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203908-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203908-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203908-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203908-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203908-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203908-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203908-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203908-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203908-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203908-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203908-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203908-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203908-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203908-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203908-004	AB	1	`2680178bc6a6…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aripiprazole	ARIPIPRAZOLE	A-S Medication Solutions	a8edb057-18a3-446d-8af0-672c97933a88	2025-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203908 application number: ANDA203908
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	385301f5-e59d-42d5-8544-aadf0ee0c967	2025-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203908 application number: ANDA203908 ndc (product): 71335-1364
Aripiprazole	ARIPIPRAZOLE	A-S Medication Solutions	c8a94428-b6d2-428b-a3a5-7b983d572fab	2024-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203908 application number: ANDA203908
Aripiprazole	ARIPIPRAZOLE	Proficient Rx LP	fbd81df7-8482-493e-bfc5-a3352f466b9e	2023-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203908 application number: ANDA203908
Aripiprazole	ARIPIPRAZOLE	Proficient Rx LP	19a3c2f2-11eb-4ec9-ac38-134168bdf99c	2022-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203908 application number: ANDA203908 ndc (product): 71205-480
Aripiprazole	ARIPIPRAZOLE	Proficient Rx LP	11202c0a-7401-41c9-b1e7-d93739fcd36f	2022-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203908 application number: ANDA203908 ndc (product): 71205-392

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 55 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-2691	Aripiprazole	Aripiprazole	A-S Medication Solutions	ANDA	Current
63739-413	Aripiprazole	Aripiprazole	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-413	Aripiprazole	Aripiprazole	McKesson Corporation dba SKY Packaging	ANDA	Current
65862-661	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-661	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-661	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-661	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-661	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-661	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-661	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-662	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-662	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-662	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-662	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-662	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-662	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-662	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-663	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-663	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-663	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-663	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-663	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-663	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-663	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-664	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-664	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-664	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-664	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-664	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-664	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-664	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-665	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-665	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-665	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-665	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-665	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-665	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-665	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-666	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-666	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-666	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-666	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-666	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-666	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
65862-666	Aripiprazole	Aripiprazole	Aurobindo Pharma Limited	ANDA	Current
70518-0759	Aripiprazole	Aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-0759	Aripiprazole	Aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-1247	Aripiprazole	Aripiprazole	REMEDYREPACK INC.	ANDA	Current
71205-392	Aripiprazole	Aripiprazole	Proficient Rx LP	ANDA	Current
71205-392	Aripiprazole	Aripiprazole	Proficient Rx LP	ANDA	Current
71205-480	Aripiprazole	Aripiprazole	Proficient Rx LP	ANDA	Current
71205-480	Aripiprazole	Aripiprazole	Proficient Rx LP	ANDA	Current
71335-1364	Aripiprazole	Aripiprazole	Bryant Ranch Prepack	ANDA	Current
71335-1364	Aripiprazole	Aripiprazole	Bryant Ranch Prepack	ANDA	Current
71335-1364	Aripiprazole	Aripiprazole	Bryant Ranch Prepack	ANDA	Current