Application 207098

Type: ANDA
Sponsor: TARO PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ILOPERIDONE	ILOPERIDONE	TABLET;ORAL	1MG	No	No
002	ILOPERIDONE	ILOPERIDONE	TABLET;ORAL	2MG	No	No
003	ILOPERIDONE	ILOPERIDONE	TABLET;ORAL	4MG	No	No
004	ILOPERIDONE	ILOPERIDONE	TABLET;ORAL	6MG	No	No
005	ILOPERIDONE	ILOPERIDONE	TABLET;ORAL	8MG	No	No
006	ILOPERIDONE	ILOPERIDONE	TABLET;ORAL	10MG	No	No
007	ILOPERIDONE	ILOPERIDONE	TABLET;ORAL	12MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A207098-001	ILOPERIDONE	ILOPERIDONE	1MG	TABLET / ORAL	2019-07-22
A207098-002	ILOPERIDONE	ILOPERIDONE	2MG	TABLET / ORAL	2019-07-22
A207098-003	ILOPERIDONE	ILOPERIDONE	4MG	TABLET / ORAL	2019-07-22
A207098-004	ILOPERIDONE	ILOPERIDONE	6MG	TABLET / ORAL	2019-07-22
A207098-005	ILOPERIDONE	ILOPERIDONE	8MG	TABLET / ORAL	2019-07-22
A207098-006	ILOPERIDONE	ILOPERIDONE	10MG	TABLET / ORAL	2019-07-22
A207098-007	ILOPERIDONE	ILOPERIDONE	12MG	TABLET / ORAL	2019-07-22

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 8 · 287 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A207098-001	ILOPERIDONE	1MG	TABLET / ORAL	2019-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207098-002	ILOPERIDONE	2MG	TABLET / ORAL	2019-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207098-003	ILOPERIDONE	4MG	TABLET / ORAL	2019-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207098-004	ILOPERIDONE	6MG	TABLET / ORAL	2019-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207098-005	ILOPERIDONE	8MG	TABLET / ORAL	2019-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207098-006	ILOPERIDONE	10MG	TABLET / ORAL	2019-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207098-007	ILOPERIDONE	12MG	TABLET / ORAL	2019-07-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207098-001	ILOPERIDONE	1MG	TABLET / ORAL	2019-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207098-002	ILOPERIDONE	2MG	TABLET / ORAL	2019-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207098-003	ILOPERIDONE	4MG	TABLET / ORAL	2019-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207098-004	ILOPERIDONE	6MG	TABLET / ORAL	2019-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207098-005	ILOPERIDONE	8MG	TABLET / ORAL	2019-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207098-006	ILOPERIDONE	10MG	TABLET / ORAL	2019-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207098-007	ILOPERIDONE	12MG	TABLET / ORAL	2019-07-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207098-001	ILOPERIDONE	1MG	TABLET / ORAL	2019-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207098-002	ILOPERIDONE	2MG	TABLET / ORAL	2019-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207098-003	ILOPERIDONE	4MG	TABLET / ORAL	2019-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207098-004	ILOPERIDONE	6MG	TABLET / ORAL	2019-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207098-005	ILOPERIDONE	8MG	TABLET / ORAL	2019-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207098-006	ILOPERIDONE	10MG	TABLET / ORAL	2019-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207098-007	ILOPERIDONE	12MG	TABLET / ORAL	2019-07-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207098-001	ILOPERIDONE	1MG	TABLET / ORAL	2019-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207098-002	ILOPERIDONE	2MG	TABLET / ORAL	2019-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207098-003	ILOPERIDONE	4MG	TABLET / ORAL	2019-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207098-004	ILOPERIDONE	6MG	TABLET / ORAL	2019-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207098-005	ILOPERIDONE	8MG	TABLET / ORAL	2019-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207098-006	ILOPERIDONE	10MG	TABLET / ORAL	2019-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207098-007	ILOPERIDONE	12MG	TABLET / ORAL	2019-07-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207098-001	ILOPERIDONE	1MG	TABLET / ORAL	2019-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207098-002	ILOPERIDONE	2MG	TABLET / ORAL	2019-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207098-003	ILOPERIDONE	4MG	TABLET / ORAL	2019-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207098-004	ILOPERIDONE	6MG	TABLET / ORAL	2019-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207098-005	ILOPERIDONE	8MG	TABLET / ORAL	2019-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207098-006	ILOPERIDONE	10MG	TABLET / ORAL	2019-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207098-007	ILOPERIDONE	12MG	TABLET / ORAL	2019-07-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207098-001	ILOPERIDONE	1MG	TABLET / ORAL	2019-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207098-002	ILOPERIDONE	2MG	TABLET / ORAL	2019-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207098-003	ILOPERIDONE	4MG	TABLET / ORAL	2019-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207098-004	ILOPERIDONE	6MG	TABLET / ORAL	2019-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207098-005	ILOPERIDONE	8MG	TABLET / ORAL	2019-07-22	`b8a1b40f171c…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FANAPT	ILOPERIDONE	Vanda Pharmaceuticals Inc.	33f60b40-3fca-11de-8f56-0002a5d5c51b	2026-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ILOPERIDONE
ILOPERIDONE	ILOPERIDONE	Mylan Pharmaceuticals Inc.	eeb0fcfd-e4e8-4fb1-9635-901dc9446235	2025-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ILOPERIDONE generic name: ILOPERIDONE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51672-4178	Iloperidone	Iloperidone	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4179	Iloperidone	Iloperidone	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4180	Iloperidone	Iloperidone	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4181	Iloperidone	Iloperidone	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4182	Iloperidone	Iloperidone	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4183	Iloperidone	Iloperidone	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4184	Iloperidone	Iloperidone	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-4213	Iloperidone	Iloperidone	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74207	ORIG	2023-05-10