Application 208055

Type: ANDA
Sponsor: TORRENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	TABLET;ORAL	20MG	No	No
002	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	TABLET;ORAL	40MG	No	No
003	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	TABLET;ORAL	80MG	No	No
004	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	TABLET;ORAL	120MG	No	No
005	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	TABLET;ORAL	60MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A208055-001	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2019-01-03
A208055-002	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2019-01-03
A208055-003	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2019-01-03
A208055-004	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2019-01-03
A208055-005	LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2025-01-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208055-001	AB
A208055-002	AB
A208055-003	AB
A208055-004	AB
A208055-005	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 3 of 5 · 185 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A208055-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	2019-01-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208055-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	2019-01-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208055-003	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	2019-01-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208055-004	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	2019-01-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208055-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	2019-01-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208055-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	2019-01-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208055-003	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	2019-01-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208055-004	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	2019-01-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208055-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	2019-01-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208055-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	2019-01-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208055-003	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	2019-01-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208055-004	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	2019-01-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208055-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	2019-01-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208055-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	2019-01-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208055-003	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	2019-01-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208055-004	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	2019-01-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208055-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	2019-01-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208055-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	2019-01-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208055-003	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	2019-01-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208055-004	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	2019-01-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208055-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	2019-01-03	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208055-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	2019-01-03	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208055-003	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	2019-01-03	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208055-004	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	2019-01-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208055-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	2019-01-03	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A208055-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	2019-01-03	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A208055-003	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	2019-01-03	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A208055-004	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	2019-01-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208055-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	2019-01-03	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A208055-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	2019-01-03	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A208055-003	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	2019-01-03	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A208055-004	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	2019-01-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208055-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	2019-01-03	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A208055-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	2019-01-03	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A208055-003	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	2019-01-03	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A208055-004	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	2019-01-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208055-001	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	2019-01-03	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A208055-002	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	2019-01-03	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A208055-003	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	2019-01-03	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A208055-004	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	2019-01-03	`3f01610625f2…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 113 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A208055-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208055-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208055-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208055-004	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208055-005	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A208055-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208055-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208055-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208055-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208055-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208055-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208055-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208055-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208055-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208055-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208055-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208055-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208055-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208055-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208055-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208055-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208055-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208055-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208055-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208055-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208055-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208055-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208055-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208055-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208055-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208055-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208055-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208055-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208055-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208055-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208055-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208055-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208055-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208055-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208055-005	AB	1	`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
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	Torrent Pharmaceuticals Limited	9cb5e275-1029-407a-8c93-ec5cde2d323b	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208055 application number: ANDA208055 ndc (product): 13668-466 ndc (product): 13668-465 ndc (product): 13668-467 ndc (product): 13668-464
Lurasidone Hydrochloride	LURASIDONE HYDROCHLORIDE	Dr. Reddys Laboratories Inc	2f22a0bd-94f3-53d7-717c-03da8e1a7e97	2023-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208055 application number: ANDA208055

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13668-464	Lurasidone Hydrochloride	Lurasidone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-464	Lurasidone Hydrochloride	Lurasidone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-465	Lurasidone Hydrochloride	Lurasidone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-465	Lurasidone Hydrochloride	Lurasidone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-466	Lurasidone Hydrochloride	Lurasidone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-466	Lurasidone Hydrochloride	Lurasidone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-467	Lurasidone Hydrochloride	Lurasidone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-467	Lurasidone Hydrochloride	Lurasidone Hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
55948	ORIG	2018-10-15