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 4 of 4 · 71 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RISPERIDONE	RISPERIDONE	Chartwell RX, LLC	66390528-7517-452a-ae76-4338ec7db3ae	2023-10-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: RISPERIDONE generic name: RISPERIDONE
Risperidone	RISPERIDONE	NCS HealthCare of KY, LLC dba Vangard Labs	7bbc37f1-6d6a-4021-8976-1f103ce1cfbd	2023-02-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Risperidone generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	Aphena Pharma Solutions - Tennessee, LLC	bda104ac-1eea-4a1a-836a-24bcc034b90f	2022-11-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: RISPERIDONE generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	Proficient Rx LP	2b9cce47-b8b3-4c9b-b26a-3d742a0db8e2	2022-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: RISPERIDONE generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	Proficient Rx LP	088dc3dd-7740-471b-8c06-5a47900ae5b5	2022-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: RISPERIDONE generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	Proficient Rx LP	1b5c9889-4dc3-48df-8629-4ac099e2b4c0	2022-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: RISPERIDONE generic name: RISPERIDONE
Risperidone	RISPERIDONE	Sun Pharmaceutical Industries, Inc.	f91f551e-926f-440d-83d2-357e9d7484fe	2022-07-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Risperidone generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	Proficient Rx LP	394c7e27-52a2-4d4c-8c6e-fe37b03266ae	2022-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: RISPERIDONE generic name: RISPERIDONE
risperidone	RISPERIDONE	Proficient Rx LP	b611fe52-1787-47e6-8a6b-1999a4e4f22c	2021-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: risperidone generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	Aphena Pharma Solutions - Tennessee, LLC	ac152803-d75f-4c3c-bc49-8663b21a3a82	2019-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: RISPERIDONE generic name: RISPERIDONE
Risperidone	RISPERIDONE	Aphena Pharma Solutions - Tennessee, LLC	58e422ec-da66-41b0-83c1-aefd940beda0	2019-04-10	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