Application 213614

Type: ANDA
Sponsor: MANKIND PHARMA

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 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
A213614-001	ALOSETRON HYDROCHLORIDE	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB		2020-09-09
A213614-002	ALOSETRON HYDROCHLORIDE	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		2020-09-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213614-001	AB
A213614-002	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 2 · 76 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
2026-08-18 06:07:40	2026-07	A213614-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2020-09-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213614-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2020-09-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213614-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2020-09-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213614-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2020-09-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213614-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2020-09-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213614-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2020-09-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213614-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2020-09-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213614-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2020-09-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213614-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2020-09-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213614-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2020-09-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213614-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2020-09-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213614-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2020-09-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213614-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2020-09-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213614-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2020-09-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213614-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2020-09-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213614-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2020-09-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213614-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2020-09-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213614-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2020-09-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213614-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2020-09-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213614-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2020-09-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213614-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2020-09-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213614-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2020-09-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213614-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2020-09-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213614-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2020-09-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213614-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2020-09-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213614-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2020-09-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213614-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2020-09-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213614-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2020-09-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213614-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2020-09-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213614-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2020-09-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213614-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2020-09-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213614-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2020-09-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213614-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2020-09-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213614-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2020-09-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213614-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2020-09-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213614-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2020-09-09	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213614-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2020-09-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213614-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2020-09-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213614-001	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET / ORAL	AB	2020-09-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213614-002	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	2020-09-09	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 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	A213614-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213614-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213614-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213614-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213614-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213614-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213614-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213614-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213614-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213614-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213614-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213614-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213614-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213614-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213614-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213614-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213614-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213614-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213614-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213614-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213614-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213614-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213614-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213614-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213614-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213614-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213614-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213614-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213614-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213614-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213614-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213614-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213614-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213614-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213614-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213614-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213614-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213614-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213614-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213614-002	AB	1	`782e0a99824c…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alosetron	ALOSETRON	Bryant Ranch Prepack	da94d161-0bf0-48fe-90f4-8e38ae18e1ca	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213614 application number: ANDA213614 ndc (product): 63629-2517
Alosetron	ALOSETRON	Bryant Ranch Prepack	38f5341f-5ae3-46bf-8bfc-30dff2068477	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213614 application number: ANDA213614 ndc (product): 63629-2518
Alosetron	ALOSETRON	Lifestar Pharma LLC	2846a244-7540-442b-81bc-638e641497ce	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213614 application number: ANDA213614 ndc (product): 70756-701 ndc (product): 70756-702

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
63629-2517	Alosetron	Alosetron	Bryant Ranch Prepack	ANDA	Current
63629-2517	Alosetron	Alosetron	Bryant Ranch Prepack	ANDA	Current
63629-2518	Alosetron	Alosetron	Bryant Ranch Prepack	ANDA	Current
63629-2518	Alosetron	Alosetron	Bryant Ranch Prepack	ANDA	Current
70756-701	Alosetron	Alosetron	Lifestar Pharma LLC	ANDA	Current
70756-701	Alosetron	Alosetron	Lifestar Pharma LLC	ANDA	Current
70756-702	Alosetron	Alosetron	Lifestar Pharma LLC	ANDA	Current
70756-702	Alosetron	Alosetron	Lifestar Pharma LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75382	SUPPL	2023-09-08