Application 078116

Type: ANDA
Sponsor: SANDOZ

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
002	RISPERIDONE	RISPERIDONE	TABLET, ORALLY DISINTEGRATING;ORAL	1MG	No	No
003	RISPERIDONE	RISPERIDONE	TABLET, ORALLY DISINTEGRATING;ORAL	2MG	No	No
004	RISPERIDONE	RISPERIDONE	TABLET, ORALLY DISINTEGRATING;ORAL	3MG	No	No
005	RISPERIDONE	RISPERIDONE	TABLET, ORALLY DISINTEGRATING;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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078116-001	RISPERIDONE	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22
A078116-002	RISPERIDONE	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22
A078116-003	RISPERIDONE	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22
A078116-004	RISPERIDONE	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22
A078116-005	RISPERIDONE	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A078116-001	AB
A078116-002	AB
A078116-003	AB
A078116-004	AB
A078116-005	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 6 · 215 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	A078116-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078116-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078116-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078116-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078116-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078116-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078116-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078116-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078116-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078116-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078116-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078116-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078116-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078116-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078116-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078116-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078116-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078116-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078116-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078116-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078116-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078116-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078116-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078116-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078116-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078116-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078116-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078116-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078116-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078116-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078116-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078116-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078116-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078116-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078116-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078116-001	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078116-002	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078116-003	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078116-004	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078116-005	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-12-22	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 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	A078116-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078116-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078116-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078116-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078116-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078116-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078116-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078116-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078116-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078116-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078116-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078116-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078116-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078116-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078116-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078116-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078116-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078116-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078116-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078116-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078116-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078116-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078116-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078116-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078116-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078116-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078116-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078116-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078116-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078116-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078116-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078116-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078116-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078116-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078116-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078116-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078116-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078116-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078116-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078116-005	AB	1	`03ed91905a0d…`

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 2 of 4 · 71 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Risperidone	RISPERIDONE	Amici Pharma, Inc.	ca41c144-224a-4d57-88d7-8778e6c69ed2	2026-03-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Risperidone generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	PD-Rx Pharmaceuticals, Inc.	bdb08381-dbfc-442e-8d3c-22d3a0f2f6c5	2026-03-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: RISPERIDONE generic name: RISPERIDONE
Risperidone	RISPERIDONE	Torrent Pharmaceuticals Limited	a6347895-5f16-43b4-92a0-b9904ac81937	2026-03-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Risperidone generic name: RISPERIDONE
risperidone	RISPERIDONE	Lupin Pharmaceuticals, Inc.	b462e48c-ef1d-4591-8fca-6b5829d8ed90	2026-02-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: risperidone generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	2776a647-678d-465c-9db3-4a9459ce779e	2026-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: RISPERIDONE generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	5d9519af-5a5e-47ce-8a0f-9b9cfac00e19	2026-01-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: RISPERIDONE generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ee7d6779-7421-4761-99d2-ccbfde9385a8	2026-01-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: RISPERIDONE generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	101b2d4d-4740-4225-94bc-aecc05d82c6b	2026-01-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: RISPERIDONE generic name: RISPERIDONE
Risperidone	RISPERIDONE	Par Health USA, LLC	d0ef6df3-67e5-47b1-bcf7-f67aa030caca	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Risperidone generic name: RISPERIDONE
risperidone	RISPERIDONE	Major Pharmaceuticals	d5abd75f-7f4a-4a7d-b849-82fce88f5ff7	2026-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: risperidone generic name: RISPERIDONE
Risperidone	RISPERIDONE	Westminster Pharmaceuticals, LLC	07d43bf6-a695-453a-a5c7-9581effe585c	2025-12-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Risperidone generic name: RISPERIDONE
Risperidone	RISPERIDONE	Golden State Medical Supply, Inc.	448467a3-44ef-c87b-e063-6294a90a5ec9	2025-11-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Risperidone generic name: RISPERIDONE
Risperidone	RISPERIDONE	American Health Packaging	f11dae15-b057-4258-9229-3819d0c980fe	2025-11-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Risperidone generic name: RISPERIDONE
RISPERDAL CONSTA	RISPERIDONE	Janssen Pharmaceuticals, Inc.	bb34ee82-d2c2-43b8-ba21-2825c0954691	2025-11-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
Risperidone	RISPERIDONE	Jubilant Cadista Pharmacuticals Inc.	739dcf8a-ed73-5eb0-899b-7e51cb73c335	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Risperidone generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	Ajanta Pharma USA Inc.	095630bd-a77e-434e-94ee-f13da445d8f2	2025-09-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: RISPERIDONE generic name: RISPERIDONE
Risperidone	RISPERIDONE	AvKARE	3d4c51e2-b09b-9fd0-e063-6294a90ae699	2025-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Risperidone generic name: RISPERIDONE
Risperidone	RISPERIDONE	Bryant Ranch Prepack	4604052d-dbda-4535-b7b8-1bd72a129aca	2025-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Risperidone generic name: RISPERIDONE
Risperidone	RISPERIDONE	NuCare Pharmaceuticals, Inc.	390904c2-fcfa-466e-e063-6394a90a03af	2025-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Risperidone generic name: RISPERIDONE
Risperidone	RISPERIDONE	Jubilant Cadista Pharmacuticals Inc.	39d41b28-93eb-446b-9652-7432858ccbab	2025-07-02	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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-5310	Risperidone	Risperidone	Sandoz Inc	ANDA	Current
0781-5310	Risperidone	Risperidone	Sandoz Inc	ANDA	Current
0781-5311	Risperidone	Risperidone	Sandoz Inc	ANDA	Current
0781-5311	Risperidone	Risperidone	Sandoz Inc	ANDA	Current
0781-5312	Risperidone	Risperidone	Sandoz Inc	ANDA	Current
0781-5312	Risperidone	Risperidone	Sandoz Inc	ANDA	Current
0781-5313	Risperidone	Risperidone	Sandoz Inc	ANDA	Current
0781-5313	Risperidone	Risperidone	Sandoz Inc	ANDA	Current
0781-5314	Risperidone	Risperidone	Sandoz Inc	ANDA	Current
0781-5314	Risperidone	Risperidone	Sandoz Inc	ANDA	Current