Application 077493

Type: ANDA
Sponsor: PRINSTON INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RISPERIDONE	RISPERIDONE	TABLET;ORAL	0.25MG	No	No
002	RISPERIDONE	RISPERIDONE	TABLET;ORAL	0.5MG	No	No
003	RISPERIDONE	RISPERIDONE	TABLET;ORAL	1MG	No	No
004	RISPERIDONE	RISPERIDONE	TABLET;ORAL	2MG	No	No
005	RISPERIDONE	RISPERIDONE	TABLET;ORAL	3MG	No	No
006	RISPERIDONE	RISPERIDONE	TABLET;ORAL	4MG	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
A077493-001	RISPERIDONE	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-11-29
A077493-002	RISPERIDONE	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-11-29
A077493-003	RISPERIDONE	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-11-29
A077493-004	RISPERIDONE	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-11-29
A077493-005	RISPERIDONE	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-11-29
A077493-006	RISPERIDONE	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077493-001	AB
A077493-002	AB
A077493-003	AB
A077493-004	AB
A077493-005	AB
A077493-006	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	A077493-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077493-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077493-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077493-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077493-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077493-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-11-29	`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	A077493-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077493-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077493-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077493-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077493-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077493-004	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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Risperidone	RISPERIDONE	Coupler LLC	55f3ebec-a742-48fc-e063-6394a90a1452	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493
Risperidone	RISPERIDONE	REMEDYREPACK INC.	c84807bd-35d7-4138-8989-42617d69293a	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493
Risperidone	RISPERIDONE	Solco Healthcare US, LLC	43aa2a4f-1123-4f86-800b-9218882f7bcd	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493 ndc (product): 43547-344 ndc (product): 43547-341 ndc (product): 43547-340 ndc (product): 43547-339 ndc (product): 43547-342 ndc (product): 43547-343
Risperidone	RISPERIDONE	REMEDYREPACK INC.	3261e8cf-cc6e-4011-9246-aee623ad8971	2025-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493
Risperidone	RISPERIDONE	REMEDYREPACK INC.	339ec0af-c0f0-4115-8cdb-8f052e633f47	2025-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493
Risperidone	RISPERIDONE	NuCare Pharmaceuticals, Inc.	390904c2-fcfa-466e-e063-6394a90a03af	2025-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493
Risperidone	RISPERIDONE	Bryant Ranch Prepack	684dcda4-d270-400c-9798-7d920a038bbb	2025-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493
Risperidone	RISPERIDONE	NCS HealthCare of KY, LLC dba Vangard Labs	7bbc37f1-6d6a-4021-8976-1f103ce1cfbd	2023-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493 ndc (product): 0615-8198 ndc (product): 0615-8197 ndc (product): 0615-8196 ndc (product): 0615-8288 ndc (product): 0615-8265
Risperidone	RISPERIDONE	Aphena Pharma Solutions - Tennessee, LLC	58e422ec-da66-41b0-83c1-aefd940beda0	2019-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493 ndc (product): 71610-259

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 41 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8196	Risperidone	Risperidone	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8196	Risperidone	Risperidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8196	Risperidone	Risperidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8197	Risperidone	Risperidone	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8197	Risperidone	Risperidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8197	Risperidone	Risperidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8198	Risperidone	Risperidone	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8198	Risperidone	Risperidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8198	Risperidone	Risperidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8265	Risperidone	Risperidone	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8265	Risperidone	Risperidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8265	Risperidone	Risperidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8288	Risperidone	Risperidone	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8288	Risperidone	Risperidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
43547-339	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-339	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-339	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-339	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-340	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-340	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-340	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-340	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-341	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-341	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-341	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-341	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-342	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-342	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-342	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-342	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-343	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-343	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-343	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-343	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-344	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-344	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-344	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
43547-344	Risperidone	Risperidone	Solco Healthcare US, LLC	ANDA	Current
70518-2969	Risperidone	Risperidone	REMEDYREPACK INC.	ANDA	Current
70518-2969	Risperidone	Risperidone	REMEDYREPACK INC.	ANDA	Current
71610-259	Risperidone	Risperidone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current