Application 077494

Type: ANDA
Sponsor: PAR PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RISPERIDONE	RISPERIDONE	TABLET, ORALLY DISINTEGRATING;ORAL	0.25MG	No	No
002	RISPERIDONE	RISPERIDONE	TABLET, ORALLY DISINTEGRATING;ORAL	0.5MG	No	No
003	RISPERIDONE	RISPERIDONE	TABLET, ORALLY DISINTEGRATING;ORAL	1MG	No	No
004	RISPERIDONE	RISPERIDONE	TABLET, ORALLY DISINTEGRATING;ORAL	2MG	No	No
005	RISPERIDONE	RISPERIDONE	TABLET, ORALLY DISINTEGRATING;ORAL	3MG	No	No
006	RISPERIDONE	RISPERIDONE	TABLET, ORALLY DISINTEGRATING;ORAL	4MG	No	No
007	RISPERIDONE	RISPERIDONE	TABLET, ORALLY DISINTEGRATING; ORAL	1MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A077494-001	RISPERIDONE	RISPERIDONE	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL		2009-04-30
A077494-002	RISPERIDONE	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30
A077494-003	RISPERIDONE	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-10-26
A077494-004	RISPERIDONE	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30
A077494-005	RISPERIDONE	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30
A077494-006	RISPERIDONE	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077494-002	AB
A077494-003	AB
A077494-004	AB
A077494-005	AB
A077494-006	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 · 246 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
2026-02-19 14:30 UTC	2026-02	A077494-001	RISPERIDONE	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL		2009-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077494-002	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077494-003	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077494-004	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077494-005	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077494-006	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077494-001	RISPERIDONE	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL		2009-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077494-002	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077494-003	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077494-004	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077494-005	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077494-006	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077494-001	RISPERIDONE	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL		2009-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077494-002	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077494-003	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077494-004	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077494-005	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077494-006	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077494-001	RISPERIDONE	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL		2009-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077494-002	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077494-003	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077494-004	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077494-005	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077494-006	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077494-001	RISPERIDONE	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL		2009-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077494-002	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077494-003	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077494-004	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077494-005	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077494-006	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077494-001	RISPERIDONE	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL		2009-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077494-002	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077494-003	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077494-004	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077494-005	RISPERIDONE	3MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077494-006	RISPERIDONE	4MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077494-001	RISPERIDONE	0.25MG	TABLET, ORALLY DISINTEGRATING / ORAL		2009-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077494-002	RISPERIDONE	0.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077494-003	RISPERIDONE	1MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077494-004	RISPERIDONE	2MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2009-04-30	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077494-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077494-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077494-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077494-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077494-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077494-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077494-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077494-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077494-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077494-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077494-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077494-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077494-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077494-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077494-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077494-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077494-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077494-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077494-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077494-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077494-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077494-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077494-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077494-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077494-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077494-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077494-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077494-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077494-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077494-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077494-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077494-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077494-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077494-005	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077494-006	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077494-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077494-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077494-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077494-005	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077494-006	AB	1	`5bbf6a4d5a75…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Risperidone	RISPERIDONE	Par Health USA, LLC	d0ef6df3-67e5-47b1-bcf7-f67aa030caca	2024-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077494 application number: ANDA077494 ndc (product): 49884-212 ndc (product): 49884-401 ndc (product): 49884-402 ndc (product): 49884-315 ndc (product): 49884-403 ndc (product): 49884-311

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49884-212	Risperidone	Risperidone	Par Pharmaceutical, Inc.	ANDA	Current
49884-212	Risperidone	Risperidone	Par Pharmaceutical, Inc.	ANDA	Current
49884-212	Risperidone	Risperidone	Par Pharmaceutical, Inc.	ANDA	Current
49884-212	Risperidone	Risperidone	Par Pharmaceutical, Inc.	ANDA	Current
49884-212	Risperidone	Risperidone	Par Pharmaceutical, Inc.	ANDA	Current
49884-311	Risperidone	Risperidone	Par Pharmaceutical, Inc.	ANDA	Current
49884-311	Risperidone	Risperidone	Par Pharmaceutical, Inc.	ANDA	Current
49884-311	Risperidone	Risperidone	Par Pharmaceutical, Inc.	ANDA	Current
49884-311	Risperidone	Risperidone	Par Pharmaceutical, Inc.	ANDA	Current
49884-311	Risperidone	Risperidone	Par Pharmaceutical, Inc.	ANDA	Current
49884-315	Risperidone	Risperidone	Par Pharmaceutical, Inc.	ANDA	Current
49884-315	Risperidone	Risperidone	Par Pharmaceutical, Inc.	ANDA	Current
49884-315	Risperidone	Risperidone	Par Pharmaceutical, Inc.	ANDA	Current
49884-315	Risperidone	Risperidone	Par Pharmaceutical, Inc.	ANDA	Current
49884-315	Risperidone	Risperidone	Par Pharmaceutical, Inc.	ANDA	Current
49884-401	Risperidone	Risperidone	Par Pharmaceutical, Inc.	ANDA	Current
49884-401	Risperidone	Risperidone	Par Pharmaceutical, Inc.	ANDA	Current
49884-401	Risperidone	Risperidone	Par Pharmaceutical, Inc.	ANDA	Current
49884-401	Risperidone	Risperidone	Par Pharmaceutical, Inc.	ANDA	Current
49884-401	Risperidone	Risperidone	Par Pharmaceutical, Inc.	ANDA	Current
49884-402	Risperidone	Risperidone	Par Pharmaceutical, Inc.	ANDA	Current
49884-402	Risperidone	Risperidone	Par Pharmaceutical, Inc.	ANDA	Current
49884-402	Risperidone	Risperidone	Par Pharmaceutical, Inc.	ANDA	Current
49884-402	Risperidone	Risperidone	Par Pharmaceutical, Inc.	ANDA	Current
49884-402	Risperidone	Risperidone	Par Pharmaceutical, Inc.	ANDA	Current
49884-403	Risperidone	Risperidone	Par Pharmaceutical, Inc.	ANDA	Current
49884-403	Risperidone	Risperidone	Par Pharmaceutical, Inc.	ANDA	Current
49884-403	Risperidone	Risperidone	Par Pharmaceutical, Inc.	ANDA	Current
49884-403	Risperidone	Risperidone	Par Pharmaceutical, Inc.	ANDA	Current
49884-403	Risperidone	Risperidone	Par Pharmaceutical, Inc.	ANDA	Current
50090-3589	Risperidone	Risperidone	A-S Medication Solutions	ANDA	Current
63629-2283	Risperidone	Risperidone	Bryant Ranch Prepack	ANDA	Current
63629-2283	Risperidone	Risperidone	Bryant Ranch Prepack	ANDA	Current
63629-2284	Risperidone	Risperidone	Bryant Ranch Prepack	ANDA	Current
63629-2284	Risperidone	Risperidone	Bryant Ranch Prepack	ANDA	Current