Application 021107

Type: NDA
Sponsor: SEBELA IRELAND LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOTRONEX	ALOSETRON HYDROCHLORIDE	TABLET;ORAL	EQ 1MG BASE	Yes	Yes
002	LOTRONEX	ALOSETRON HYDROCHLORIDE	TABLET;ORAL	EQ 0.5MG BASE	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021107-001	LOTRONEX	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2000-02-09
N021107-002	LOTRONEX	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2003-12-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N021107-001	AB
N021107-002	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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021107-001	LOTRONEX	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2000-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021107-002	LOTRONEX	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2003-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021107-001	LOTRONEX	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2000-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021107-002	LOTRONEX	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2003-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021107-001	LOTRONEX	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2000-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021107-002	LOTRONEX	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2003-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021107-001	LOTRONEX	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2000-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021107-002	LOTRONEX	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2003-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021107-001	LOTRONEX	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2000-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021107-002	LOTRONEX	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2003-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021107-001	LOTRONEX	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2000-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021107-002	LOTRONEX	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2003-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021107-001	LOTRONEX	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2000-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021107-002	LOTRONEX	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2003-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021107-001	LOTRONEX	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2000-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021107-002	LOTRONEX	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2003-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021107-001	LOTRONEX	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2000-02-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021107-002	LOTRONEX	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2003-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021107-001	LOTRONEX	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2000-02-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021107-002	LOTRONEX	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2003-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021107-001	LOTRONEX	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2000-02-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021107-002	LOTRONEX	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2003-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021107-001	LOTRONEX	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2000-02-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021107-002	LOTRONEX	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2003-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021107-001	LOTRONEX	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2000-02-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021107-002	LOTRONEX	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2003-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021107-001	LOTRONEX	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2000-02-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021107-002	LOTRONEX	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2003-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021107-001	LOTRONEX	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2000-02-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021107-002	LOTRONEX	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2003-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021107-001	LOTRONEX	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2000-02-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021107-002	LOTRONEX	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2003-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021107-001	LOTRONEX	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2000-02-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021107-002	LOTRONEX	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2003-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021107-001	LOTRONEX	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2000-02-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021107-002	LOTRONEX	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2003-12-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021107-001	LOTRONEX	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2000-02-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021107-002	LOTRONEX	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2003-12-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021107-001	LOTRONEX	EQ 1MG BASE	TABLET / ORAL	AB	RLD, RS	2000-02-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021107-002	LOTRONEX	EQ 0.5MG BASE	TABLET / ORAL	AB	RLD	2003-12-23	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021107-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021107-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021107-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021107-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021107-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021107-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021107-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021107-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021107-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021107-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021107-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021107-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021107-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021107-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021107-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021107-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021107-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021107-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021107-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021107-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021107-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021107-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021107-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021107-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021107-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021107-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021107-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021107-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021107-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021107-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021107-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021107-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021107-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021107-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021107-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021107-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021107-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021107-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021107-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021107-002	AB	1	`bb7c543d1eb4…`

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
LOTRONEX	ALOSETRON HYDROCHLORIDE	Sebela Pharmaceuticals Inc.	35cbb9d5-639b-207a-e054-00144ff88e88	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021107 application number: NDA021107 ndc (product): 54766-894 ndc (product): 54766-895
LOTRONEX	ALOSETRON HYDROCHLORIDE	Legacy Pharma USA Inc.	c216e967-436f-475a-8e6a-2ad11adc63af	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021107 application number: NDA021107

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
45963-479	Alosetron Hydrochloride	alosetron hydrochloride	Actavis Pharma, Inc.	NDA	Current
45963-479	Alosetron Hydrochloride	alosetron hydrochloride	Actavis Pharma, Inc.	NDA	Current
45963-480	Alosetron Hydrochloride	alosetron hydrochloride	Actavis Pharma, Inc.	NDA	Current
45963-480	Alosetron Hydrochloride	alosetron hydrochloride	Actavis Pharma, Inc.	NDA	Current
54766-894	LOTRONEX	alosetron hydrochloride	Sebela Pharmaceuticals Inc.	NDA	Current
54766-894	LOTRONEX	alosetron hydrochloride	Sebela Pharmaceuticals Inc.	NDA	Current
54766-895	LOTRONEX	alosetron hydrochloride	Sebela Pharmaceuticals Inc.	NDA	Current
54766-895	LOTRONEX	alosetron hydrochloride	Sebela Pharmaceuticals Inc.	NDA	Current
65483-894	LOTRONEX	alosetron hydrochloride	Prometheus Laboratories Inc.	NDA	Current
65483-895	LOTRONEX	alosetron hydrochloride	Prometheus Laboratories Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75383	SUPPL	2023-09-11
58210	SUPPL	2019-04-04
58199	SUPPL	2019-04-04
48424	SUPPL	2017-05-17
14394	SUPPL	2016-01-26
26774	SUPPL	2016-01-11
26773	SUPPL	2016-01-11
4341	SUPPL	2015-07-27
26772	SUPPL	2014-05-12
36122	SUPPL	2010-10-01
23988	ORIG	2010-10-01
43708	ORIG	2010-09-15
26771	SUPPL	2010-09-07
14393	SUPPL	2010-09-07
4340	SUPPL	2010-09-07
36121	SUPPL	2008-05-06
4339	SUPPL	2008-04-09
41953	SUPPL	2007-11-19
21456	SUPPL	2007-11-19
21455	SUPPL	2007-11-19
21454	SUPPL	2007-11-19
4338	SUPPL	2006-03-23
14392	SUPPL	2006-03-14
14391	SUPPL	2005-02-23
4337	SUPPL	2005-02-23
4336	SUPPL	2005-02-08
14390	SUPPL	2005-02-04
36120	SUPPL	2003-12-29
4335	SUPPL	2003-12-24
44098	ORIG	2003-12-17
26770	SUPPL	2003-03-26
14389	SUPPL	2002-06-07
4334	SUPPL	2002-06-07
21453	ORIG	2000-08-29
36119	ORIG	2000-02-09
26769	ORIG	2000-02-09