Application 078707

Type: ANDA
Sponsor: RENATA

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
A078707-001	RISPERIDONE	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-12-29
A078707-002	RISPERIDONE	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-12-29
A078707-003	RISPERIDONE	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-12-29
A078707-004	RISPERIDONE	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-12-29
A078707-005	RISPERIDONE	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-12-29
A078707-006	RISPERIDONE	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-12-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078707-001	AB
A078707-002	AB
A078707-003	AB
A078707-004	AB
A078707-005	AB
A078707-006	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	A078707-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078707-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078707-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078707-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078707-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078707-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078707-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078707-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078707-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078707-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078707-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078707-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078707-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078707-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078707-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078707-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078707-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078707-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078707-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078707-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078707-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078707-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078707-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078707-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078707-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078707-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078707-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078707-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-12-29	`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	A078707-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078707-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078707-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078707-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078707-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078707-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078707-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078707-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078707-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078707-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078707-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078707-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078707-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078707-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078707-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078707-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078707-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078707-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078707-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078707-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078707-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078707-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078707-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078707-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078707-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078707-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078707-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078707-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078707-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078707-004	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
Risperidone	RISPERIDONE	Westminster Pharmaceuticals, LLC	07d43bf6-a695-453a-a5c7-9581effe585c	2025-12-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078707 application number: ANDA078707
Risperidone	RISPERIDONE	AvKARE	3d4c51e2-b09b-9fd0-e063-6294a90ae699	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078707 application number: ANDA078707
Risperidone	RISPERIDONE	AvKARE	2f9ea0cc-b86b-a11f-e063-6294a90a9620	2025-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078707 application number: ANDA078707

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
53808-0909	Risperidone	risperidone	State of Florida DOH Central Pharmacy	ANDA	Current
53808-1048	Risperidone	risperidone	State of Florida DOH Central Pharmacy	ANDA	Current
63187-209	Risperidone	risperidone	Proficient Rx LP	ANDA	Current
63187-210	Risperidone	risperidone	Proficient Rx LP	ANDA	Current
63187-211	Risperidone	risperidone	Proficient Rx LP	ANDA	Current
63629-3354	Risperidone	risperidone	Bryant Ranch Prepack	ANDA	Current
63629-3355	Risperidone	risperidone	Bryant Ranch Prepack	ANDA	Current
63629-4504	Risperidone	risperidone	Bryant Ranch Prepack	ANDA	Current
63629-4505	Risperidone	risperidone	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44394	ORIG	2009-01-06