Application 076288

Type: ANDA
Sponsor: MYLAN

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	Approval date
A076288-001	RISPERIDONE	RISPERIDONE	0.25MG	TABLET / ORAL	2008-09-15
A076288-002	RISPERIDONE	RISPERIDONE	0.5MG	TABLET / ORAL	2008-09-15
A076288-003	RISPERIDONE	RISPERIDONE	1MG	TABLET / ORAL	2008-09-15
A076288-004	RISPERIDONE	RISPERIDONE	2MG	TABLET / ORAL	2008-09-15
A076288-005	RISPERIDONE	RISPERIDONE	3MG	TABLET / ORAL	2008-09-15
A076288-006	RISPERIDONE	RISPERIDONE	4MG	TABLET / ORAL	2008-09-15

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076288-001	RISPERIDONE	0.25MG	TABLET / ORAL	2008-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076288-002	RISPERIDONE	0.5MG	TABLET / ORAL	2008-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076288-003	RISPERIDONE	1MG	TABLET / ORAL	2008-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076288-004	RISPERIDONE	2MG	TABLET / ORAL	2008-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076288-005	RISPERIDONE	3MG	TABLET / ORAL	2008-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076288-006	RISPERIDONE	4MG	TABLET / ORAL	2008-09-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076288-001	RISPERIDONE	0.25MG	TABLET / ORAL	2008-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076288-002	RISPERIDONE	0.5MG	TABLET / ORAL	2008-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076288-003	RISPERIDONE	1MG	TABLET / ORAL	2008-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076288-004	RISPERIDONE	2MG	TABLET / ORAL	2008-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076288-005	RISPERIDONE	3MG	TABLET / ORAL	2008-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076288-006	RISPERIDONE	4MG	TABLET / ORAL	2008-09-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076288-001	RISPERIDONE	0.25MG	TABLET / ORAL	2008-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076288-002	RISPERIDONE	0.5MG	TABLET / ORAL	2008-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076288-003	RISPERIDONE	1MG	TABLET / ORAL	2008-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076288-004	RISPERIDONE	2MG	TABLET / ORAL	2008-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076288-005	RISPERIDONE	3MG	TABLET / ORAL	2008-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076288-006	RISPERIDONE	4MG	TABLET / ORAL	2008-09-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076288-001	RISPERIDONE	0.25MG	TABLET / ORAL	2008-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076288-002	RISPERIDONE	0.5MG	TABLET / ORAL	2008-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076288-003	RISPERIDONE	1MG	TABLET / ORAL	2008-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076288-004	RISPERIDONE	2MG	TABLET / ORAL	2008-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076288-005	RISPERIDONE	3MG	TABLET / ORAL	2008-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076288-006	RISPERIDONE	4MG	TABLET / ORAL	2008-09-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076288-001	RISPERIDONE	0.25MG	TABLET / ORAL	2008-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076288-002	RISPERIDONE	0.5MG	TABLET / ORAL	2008-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076288-003	RISPERIDONE	1MG	TABLET / ORAL	2008-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076288-004	RISPERIDONE	2MG	TABLET / ORAL	2008-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076288-005	RISPERIDONE	3MG	TABLET / ORAL	2008-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076288-006	RISPERIDONE	4MG	TABLET / ORAL	2008-09-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076288-001	RISPERIDONE	0.25MG	TABLET / ORAL	2008-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076288-002	RISPERIDONE	0.5MG	TABLET / ORAL	2008-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076288-003	RISPERIDONE	1MG	TABLET / ORAL	2008-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076288-004	RISPERIDONE	2MG	TABLET / ORAL	2008-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076288-005	RISPERIDONE	3MG	TABLET / ORAL	2008-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076288-006	RISPERIDONE	4MG	TABLET / ORAL	2008-09-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076288-001	RISPERIDONE	0.25MG	TABLET / ORAL	2008-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076288-002	RISPERIDONE	0.5MG	TABLET / ORAL	2008-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076288-003	RISPERIDONE	1MG	TABLET / ORAL	2008-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076288-004	RISPERIDONE	2MG	TABLET / ORAL	2008-09-15	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076288-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076288-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076288-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076288-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076288-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076288-006	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A076288-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076288-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076288-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076288-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076288-005	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076288-006	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076288-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076288-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076288-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076288-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076288-005	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076288-006	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076288-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076288-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076288-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076288-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076288-005	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076288-006	AB	1	`ea99ee380514…`

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 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-3502	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3502	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3502	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3505	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3505	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3505	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3511	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3511	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3511	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3512	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3512	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3512	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3513	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3513	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3513	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3514	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3514	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3514	Risperidone	risperidone	Mylan Pharmaceuticals Inc.	ANDA	Current
0615-7505	Risperidone	risperidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7506	Risperidone	risperidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7506	Risperidone	risperidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7507	Risperidone	risperidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7507	Risperidone	risperidone	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
43353-754	Risperidone	risperidone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-755	Risperidone	risperidone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-757	Risperidone	risperidone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-766	Risperidone	risperidone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
51079-460	Risperidone	risperidone	Mylan Institutional Inc.	ANDA	Current
51079-461	Risperidone	risperidone	Mylan Institutional Inc.	ANDA	Current
51079-462	Risperidone	risperidone	Mylan Institutional Inc.	ANDA	Current
51079-462	Risperidone	risperidone	Mylan Institutional Inc.	ANDA	Current
51079-463	Risperidone	risperidone	Mylan Institutional Inc.	ANDA	Current
51079-463	Risperidone	risperidone	Mylan Institutional Inc.	ANDA	Current
51079-463	Risperidone	risperidone	Mylan Institutional Inc.	ANDA	Current
51079-464	Risperidone	risperidone	Mylan Institutional Inc.	ANDA	Current
51079-464	Risperidone	risperidone	Mylan Institutional Inc.	ANDA	Current
51079-464	Risperidone	risperidone	Mylan Institutional Inc.	ANDA	Current
51079-465	Risperidone	risperidone	Mylan Institutional Inc.	ANDA	Current
51079-465	Risperidone	risperidone	Mylan Institutional Inc.	ANDA	Current
51079-465	Risperidone	risperidone	Mylan Institutional Inc.	ANDA	Current
53808-0624	Risperidone	risperidone	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0876	Risperidone	risperidone	State of Florida DOH Central Pharmacy	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44300	ORIG	2008-09-19