Application 205363

Type: ANDA
Sponsor: PRINSTON INC

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
A205363-001	ARIPIPRAZOLE	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2017-12-04
A205363-002	ARIPIPRAZOLE	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2017-12-04
A205363-003	ARIPIPRAZOLE	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2017-12-04
A205363-004	ARIPIPRAZOLE	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2017-12-04
A205363-005	ARIPIPRAZOLE	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2017-12-04
A205363-006	ARIPIPRAZOLE	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2017-12-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205363-001	AB
A205363-002	AB
A205363-003	AB
A205363-004	AB
A205363-005	AB
A205363-006	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	A205363-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2017-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205363-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2017-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205363-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2017-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205363-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2017-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205363-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2017-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205363-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2017-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205363-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2017-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205363-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2017-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205363-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2017-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205363-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2017-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205363-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2017-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205363-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2017-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205363-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2017-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205363-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2017-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205363-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2017-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205363-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2017-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205363-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2017-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205363-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2017-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205363-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2017-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205363-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2017-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205363-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2017-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205363-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2017-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205363-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2017-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205363-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2017-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205363-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2017-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205363-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2017-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205363-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2017-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205363-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2017-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205363-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2017-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205363-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2017-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205363-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2017-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205363-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2017-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205363-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2017-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205363-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2017-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205363-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2017-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205363-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2017-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205363-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2017-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205363-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2017-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205363-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2017-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205363-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2017-12-04	`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	A205363-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205363-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205363-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205363-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205363-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205363-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205363-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205363-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205363-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205363-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205363-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205363-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205363-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205363-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205363-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205363-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205363-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205363-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205363-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205363-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205363-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205363-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205363-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205363-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205363-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205363-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205363-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205363-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205363-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205363-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205363-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205363-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205363-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205363-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205363-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205363-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205363-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205363-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205363-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205363-004	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ARIPIPRAZOLE	ARIPIPRAZOLE	Solco Healthcare U.S., LLC	abb8ad7e-7998-4485-a09f-a2892190f4ad	2024-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205363 application number: ANDA205363
ARIPIPRAZOLE	ARIPIPRAZOLE	A-S Medication Solutions	db6fc74e-4989-464d-9c19-a5b7a541fd46	2024-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205363 application number: ANDA205363
ARIPIPRAZOLE	ARIPIPRAZOLE	Solco Healthcare U.S., LLC	686d0088-ac61-41df-8909-ae12f7957644	2023-04-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205363 application number: ANDA205363 ndc (product): 43547-302 ndc (product): 43547-304 ndc (product): 43547-307 ndc (product): 43547-303 ndc (product): 43547-305 ndc (product): 43547-306

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43547-302	ARIPIPRAZOLE	aripiprazole	Solco Healthcare U.S., LLC	ANDA	Current
43547-302	ARIPIPRAZOLE	aripiprazole	Solco Healthcare U.S., LLC	ANDA	Current
43547-302	ARIPIPRAZOLE	aripiprazole	Solco Healthcare U.S., LLC	ANDA	Current
43547-303	ARIPIPRAZOLE	aripiprazole	Solco Healthcare U.S., LLC	ANDA	Current
43547-303	ARIPIPRAZOLE	aripiprazole	Solco Healthcare U.S., LLC	ANDA	Current
43547-303	ARIPIPRAZOLE	aripiprazole	Solco Healthcare U.S., LLC	ANDA	Current
43547-304	ARIPIPRAZOLE	aripiprazole	Solco Healthcare U.S., LLC	ANDA	Current
43547-304	ARIPIPRAZOLE	aripiprazole	Solco Healthcare U.S., LLC	ANDA	Current
43547-304	ARIPIPRAZOLE	aripiprazole	Solco Healthcare U.S., LLC	ANDA	Current
43547-305	ARIPIPRAZOLE	aripiprazole	Solco Healthcare U.S., LLC	ANDA	Current
43547-305	ARIPIPRAZOLE	aripiprazole	Solco Healthcare U.S., LLC	ANDA	Current
43547-305	ARIPIPRAZOLE	aripiprazole	Solco Healthcare U.S., LLC	ANDA	Current
43547-306	ARIPIPRAZOLE	aripiprazole	Solco Healthcare U.S., LLC	ANDA	Current
43547-306	ARIPIPRAZOLE	aripiprazole	Solco Healthcare U.S., LLC	ANDA	Current
43547-306	ARIPIPRAZOLE	aripiprazole	Solco Healthcare U.S., LLC	ANDA	Current
43547-307	ARIPIPRAZOLE	aripiprazole	Solco Healthcare U.S., LLC	ANDA	Current
43547-307	ARIPIPRAZOLE	aripiprazole	Solco Healthcare U.S., LLC	ANDA	Current
43547-307	ARIPIPRAZOLE	aripiprazole	Solco Healthcare U.S., LLC	ANDA	Current
70518-2508	ARIPIPRAZOLE	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2508	ARIPIPRAZOLE	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2508	ARIPIPRAZOLE	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2515	ARIPIPRAZOLE	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2515	ARIPIPRAZOLE	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2669	ARIPIPRAZOLE	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2669	ARIPIPRAZOLE	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2669	ARIPIPRAZOLE	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2827	ARIPIPRAZOLE	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2827	ARIPIPRAZOLE	aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-2827	ARIPIPRAZOLE	aripiprazole	REMEDYREPACK INC.	ANDA	Current