Application 078516

Type: ANDA
Sponsor: ZYDUS PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RISPERIDONE	RISPERIDONE	TABLET, ORALLY DISINTEGRATING;ORAL	0.5MG	No	No
003	RISPERIDONE	RISPERIDONE	TABLET, ORALLY DISINTEGRATING;ORAL	2MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078516-001	RISPERIDONE	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-05-01
A078516-003	RISPERIDONE	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2009-05-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A078516-001	AB
A078516-003	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 3 · 86 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	A078516-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078516-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078516-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078516-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078516-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078516-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078516-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078516-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078516-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078516-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078516-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078516-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078516-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078516-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078516-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078516-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078516-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078516-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078516-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078516-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078516-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078516-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078516-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078516-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078516-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078516-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078516-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078516-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078516-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078516-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078516-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078516-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078516-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078516-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078516-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078516-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078516-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078516-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078516-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078516-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-05-01	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A078516-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078516-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078516-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078516-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078516-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078516-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078516-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078516-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078516-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078516-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078516-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078516-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078516-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078516-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078516-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078516-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078516-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078516-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078516-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078516-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078516-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078516-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078516-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078516-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078516-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078516-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078516-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078516-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078516-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078516-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078516-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078516-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078516-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078516-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078516-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078516-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078516-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078516-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078516-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078516-003	AB	1	`74a2ff9319b5…`

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 3 of 4 · 71 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
risperidone	RISPERIDONE	Zydus Pharmaceuticals USA Inc.	713b5ac7-53d6-4139-8599-3028f789de4b	2025-06-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: risperidone generic name: RISPERIDONE
Risperidone	RISPERIDONE	Bryant Ranch Prepack	684dcda4-d270-400c-9798-7d920a038bbb	2025-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Risperidone generic name: RISPERIDONE
Risperidone	RISPERIDONE	Cranbury Pharmaceuticals, LLC	a0a21bec-68f0-444e-a611-d0602859410c	2025-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Risperidone generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	PD-Rx Pharmaceuticals, Inc.	be388943-fe0c-4c82-ac8e-3df9f77b2891	2025-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: RISPERIDONE generic name: RISPERIDONE
Risperidone	RISPERIDONE	Bryant Ranch Prepack	3cc027f0-3462-4a2f-925b-d8a529bcb3c3	2025-03-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Risperidone generic name: RISPERIDONE
Risperidone	RISPERIDONE	AvKARE	2f9ea0cc-b86b-a11f-e063-6294a90a9620	2025-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Risperidone generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	Aurobindo Pharma Limited	c4582bdf-5eda-438c-98b4-0517500501e8	2025-03-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: RISPERIDONE generic name: RISPERIDONE
Risperidone	RISPERIDONE	Teva Pharmaceuticals, Inc.	32c0f081-b418-4c1c-b39e-eb5c344043c7	2025-02-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Risperidone generic name: RISPERIDONE
Risperidone	RISPERIDONE	Amneal Pharmaceuticals NY LLC	e90c886c-132a-4df6-8604-cfe5ffa49d5b	2025-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Risperidone generic name: RISPERIDONE
Risperidone	RISPERIDONE	Amneal Pharmaceuticals LLC	bc55f60a-8121-44bb-bdfc-1d311879ba4f	2025-02-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Risperidone generic name: RISPERIDONE
Risperidone	RISPERIDONE	Direct_Rx	0b784f21-fc02-6542-e063-6294a90a285e	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Risperidone generic name: RISPERIDONE
risperidone	RISPERIDONE	Zydus Lifesciences Limited	23993d21-80bf-41c4-b57d-88a620173b6b	2024-08-12		Name fallback brand name: risperidone generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	NuCare Pharmaceuticals,Inc.	79648a52-1364-c25b-e053-2a91aa0a8ea4	2024-06-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: RISPERIDONE generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	Bryant Ranch Prepack	420cfeef-0061-43b9-9491-dbd6ad866e55	2024-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: RISPERIDONE generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	Bryant Ranch Prepack	aab773b2-a605-4cf8-a301-57e390fe67a6	2024-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: RISPERIDONE generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	Bryant Ranch Prepack	2f83d3e9-04ab-4b24-ad1f-7ed2e784298a	2024-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: RISPERIDONE generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	Bryant Ranch Prepack	e35be034-6275-41fb-bec4-9ae451458701	2024-04-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: RISPERIDONE generic name: RISPERIDONE
Risperidone	RISPERIDONE	Chartwell RX, LLC	12a479c4-a84a-4308-b89f-be0315826fd5	2024-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Risperidone generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	A-S Medication Solutions	523d4f99-1d6f-413f-9d6e-2ca430aaac14	2024-01-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: RISPERIDONE generic name: RISPERIDONE
Risperidone	RISPERIDONE	Natco Pharma USA LLC	856d65dc-f330-4195-b271-d0bdbe99519d	2023-11-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Risperidone generic name: RISPERIDONE

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 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65841-640	risperidone	risperidone	Zydus Lifesciences Limited	ANDA	Current
65841-640	risperidone	risperidone	Cadila Healthcare Limited	ANDA	Current
65841-640	risperidone	risperidone	Cadila Healthcare Limited	ANDA	Current
65841-641	risperidone	risperidone	Zydus Lifesciences Limited	ANDA	Current
65841-641	risperidone	risperidone	Cadila Healthcare Limited	ANDA	Current
65841-641	risperidone	risperidone	Cadila Healthcare Limited	ANDA	Current
65841-642	risperidone	risperidone	Zydus Lifesciences Limited	ANDA	Current
65841-642	risperidone	risperidone	Cadila Healthcare Limited	ANDA	Current
65841-642	risperidone	risperidone	Cadila Healthcare Limited	ANDA	Current
68382-154	risperidone	risperidone	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-154	risperidone	risperidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-154	risperidone	risperidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-155	risperidone	risperidone	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-155	risperidone	risperidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-155	risperidone	risperidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-156	risperidone	risperidone	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-156	risperidone	risperidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-156	risperidone	risperidone	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current