Application 078040

Type: ANDA
Sponsor: ZYDUS PHARMS USA 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 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
A078040-001	RISPERIDONE	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-16
A078040-002	RISPERIDONE	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-16
A078040-003	RISPERIDONE	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-16
A078040-004	RISPERIDONE	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-16
A078040-005	RISPERIDONE	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-16
A078040-006	RISPERIDONE	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078040-001	AB
A078040-002	AB
A078040-003	AB
A078040-004	AB
A078040-005	AB
A078040-006	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	A078040-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078040-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078040-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078040-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078040-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078040-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078040-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078040-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078040-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078040-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078040-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078040-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078040-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078040-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2008-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2008-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2008-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2008-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2008-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2008-10-16	`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	A078040-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078040-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078040-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078040-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078040-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078040-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078040-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078040-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078040-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078040-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078040-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078040-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078040-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078040-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078040-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078040-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078040-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078040-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078040-004	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 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
risperidone	RISPERIDONE	Cardinal Health 107, LLC	3ce21196-4aa0-469b-8f04-6650b2c48cb5	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078040 application number: ANDA078040
risperidone	RISPERIDONE	Major Pharmaceuticals	d5abd75f-7f4a-4a7d-b849-82fce88f5ff7	2026-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078040 application number: ANDA078040
Risperidone	RISPERIDONE	American Health Packaging	f11dae15-b057-4258-9229-3819d0c980fe	2025-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078040 application number: ANDA078040
risperidone	RISPERIDONE	Zydus Pharmaceuticals USA Inc.	713b5ac7-53d6-4139-8599-3028f789de4b	2025-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078040 application number: ANDA078040 ndc (product): 68382-114 ndc (product): 68382-115 ndc (product): 68382-113 ndc (product): 68382-117 ndc (product): 68382-116 ndc (product): 68382-112
risperidone	RISPERIDONE	Zydus Lifesciences Limited	23993d21-80bf-41c4-b57d-88a620173b6b	2024-08-12		Exact identifier application applno (ANDA): 078040 application number: ANDA078040
risperidone	RISPERIDONE	Proficient Rx LP	b611fe52-1787-47e6-8a6b-1999a4e4f22c	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078040 application number: ANDA078040

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 · 132 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68382-112	risperidone	risperidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-112	risperidone	risperidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-113	risperidone	risperidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-113	risperidone	risperidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-113	risperidone	risperidone	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-113	risperidone	risperidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-113	risperidone	risperidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-114	risperidone	risperidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-114	risperidone	risperidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-114	risperidone	risperidone	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-114	risperidone	risperidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-114	risperidone	risperidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-115	risperidone	risperidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-115	risperidone	risperidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-115	risperidone	risperidone	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-115	risperidone	risperidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-115	risperidone	risperidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-116	risperidone	risperidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-116	risperidone	risperidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-116	risperidone	risperidone	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-116	risperidone	risperidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-116	risperidone	risperidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-117	risperidone	risperidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-117	risperidone	risperidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-117	risperidone	risperidone	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-117	risperidone	risperidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-117	risperidone	risperidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70518-0978	risperidone	risperidone	REMEDYREPACK INC.	ANDA	Current
70518-0978	risperidone	risperidone	REMEDYREPACK INC.	ANDA	Current
70518-0978	risperidone	risperidone	REMEDYREPACK INC.	ANDA	Current
70518-0978	risperidone	risperidone	REMEDYREPACK INC.	ANDA	Current
70518-0978	risperidone	risperidone	REMEDYREPACK INC.	ANDA	Current
70518-0979	risperidone	risperidone	REMEDYREPACK INC.	ANDA	Current
70518-0979	risperidone	risperidone	REMEDYREPACK INC.	ANDA	Current
70518-1151	risperidone	risperidone	REMEDYREPACK INC.	ANDA	Current
70518-1151	risperidone	risperidone	REMEDYREPACK INC.	ANDA	Current
70518-1151	risperidone	risperidone	REMEDYREPACK INC.	ANDA	Current
70518-1151	risperidone	risperidone	REMEDYREPACK INC.	ANDA	Current
70518-1151	risperidone	risperidone	REMEDYREPACK INC.	ANDA	Current
70518-1574	risperidone	risperidone	REMEDYREPACK INC.	ANDA	Current
70518-1574	risperidone	risperidone	REMEDYREPACK INC.	ANDA	Current
70518-1574	risperidone	risperidone	REMEDYREPACK INC.	ANDA	Current
70518-1574	risperidone	risperidone	REMEDYREPACK INC.	ANDA	Current
70518-1574	risperidone	risperidone	REMEDYREPACK INC.	ANDA	Current
70518-1574	risperidone	risperidone	REMEDYREPACK INC.	ANDA	Current
70518-1574	risperidone	risperidone	REMEDYREPACK INC.	ANDA	Current
70518-2096	risperidone	risperidone	REMEDYREPACK INC.	ANDA	Current
70518-2130	risperidone	risperidone	REMEDYREPACK INC.	ANDA	Current
70518-2130	risperidone	risperidone	REMEDYREPACK INC.	ANDA	Current
70518-2130	risperidone	risperidone	REMEDYREPACK INC.	ANDA	Current
70518-2130	risperidone	risperidone	REMEDYREPACK INC.	ANDA	Current
70518-2130	risperidone	risperidone	REMEDYREPACK INC.	ANDA	Current