Application 206113

Type: ANDA
Sponsor: PAR PHARM INC

Application Products#

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

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

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
A206113-001	ALOSETRON HYDROCHLORIDE	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL			2018-02-23
A206113-002	ALOSETRON HYDROCHLORIDE	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL			2018-02-23

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 · 82 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	A206113-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL		2018-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206113-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL		2018-02-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206113-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL		2018-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206113-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL		2018-02-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206113-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL		2018-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206113-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL		2018-02-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206113-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL		2018-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206113-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL		2018-02-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206113-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL		2018-02-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206113-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL		2018-02-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206113-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL		2018-02-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206113-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL		2018-02-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206113-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL		2018-02-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206113-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL		2018-02-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206113-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL		2018-02-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206113-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL		2018-02-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206113-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL		2018-02-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206113-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL		2018-02-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206113-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL		2018-02-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206113-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL		2018-02-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206113-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL		2018-02-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206113-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL		2018-02-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206113-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL		2018-02-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206113-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL		2018-02-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206113-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL		2018-02-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206113-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL		2018-02-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206113-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL		2018-02-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206113-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL		2018-02-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206113-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL		2018-02-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206113-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL		2018-02-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206113-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2018-02-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206113-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2018-02-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206113-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2018-02-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206113-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2018-02-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206113-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2018-02-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206113-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2018-02-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206113-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2018-02-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206113-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2018-02-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206113-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2018-02-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206113-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2018-02-23	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A206113-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206113-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206113-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206113-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206113-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206113-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206113-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206113-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206113-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206113-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206113-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206113-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206113-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206113-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206113-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206113-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206113-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206113-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206113-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206113-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206113-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206113-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206113-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206113-002	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 1 of 1 · 6 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	Name fallback generic name: ALOSETRON HYDROCHLORIDE
LOTRONEX	ALOSETRON HYDROCHLORIDE	Legacy Pharma USA Inc.	c216e967-436f-475a-8e6a-2ad11adc63af	2026-03-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ALOSETRON HYDROCHLORIDE
Alosetron Hydrochloride	ALOSETRON HYDROCHLORIDE	Eywa Pharma Inc	d62b2c5a-1693-4e67-96d5-197e1fdc8694	2025-10-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alosetron Hydrochloride generic name: ALOSETRON HYDROCHLORIDE
Alosetron Hydrochloride	ALOSETRON HYDROCHLORIDE	AvKARE	3ac203a2-4c55-deac-e063-6394a90aa165	2025-09-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alosetron Hydrochloride generic name: ALOSETRON HYDROCHLORIDE
Alosetron Hydrochloride	ALOSETRON HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	2927e7d0-b1b8-4944-a7e8-97b60eb9bb71	2023-03-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alosetron Hydrochloride generic name: ALOSETRON HYDROCHLORIDE
Alosetron Hydrochloride	ALOSETRON HYDROCHLORIDE	Amneal Pharmaceuticals LLC	ba94ab71-11d7-4ce1-9b21-0b8c6a39e993	2022-05-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Alosetron Hydrochloride generic name: ALOSETRON HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49884-819	ALOSETRON HYDROCHLORIDE	ALOSETRON HYDROCHLORIDE	Par Pharmaceutical, Inc.	ANDA	Current
49884-819	ALOSETRON HYDROCHLORIDE	ALOSETRON HYDROCHLORIDE	Par Pharmaceutical, Inc.	ANDA	Current
49884-819	ALOSETRON HYDROCHLORIDE	ALOSETRON HYDROCHLORIDE	Par Pharmaceutical, Inc.	ANDA	Current
49884-820	ALOSETRON HYDROCHLORIDE	ALOSETRON HYDROCHLORIDE	Par Pharmaceutical, Inc.	ANDA	Current
49884-820	ALOSETRON HYDROCHLORIDE	ALOSETRON HYDROCHLORIDE	Par Pharmaceutical, Inc.	ANDA	Current
49884-820	ALOSETRON HYDROCHLORIDE	ALOSETRON HYDROCHLORIDE	Par Pharmaceutical, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75380	SUPPL	2023-09-08