Application 209450

Type: ANDA
Sponsor: AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LUBIPROSTONE	LUBIPROSTONE	CAPSULE;ORAL	8MCG	No	No
002	LUBIPROSTONE	LUBIPROSTONE	CAPSULE;ORAL	24MCG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A209450-001	LUBIPROSTONE	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB		2021-11-30
A209450-002	LUBIPROSTONE	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB		2021-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209450-001	AB
A209450-002	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 · 70 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
2026-09-14 22:38:34	2026-08	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL		2021-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL		2021-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL		2021-11-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL		2021-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209450-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209450-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209450-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209450-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209450-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209450-002	AB	1	`011fe1cb6892…`
2025-08-23 18:47 UTC	2025-08	A209450-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209450-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209450-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209450-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209450-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209450-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209450-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209450-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209450-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209450-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209450-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209450-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209450-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209450-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209450-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209450-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209450-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209450-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209450-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209450-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209450-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209450-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209450-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209450-002	AB	1	`8072bd15b7f6…`
2022-04-08 23:34 UTC	2022-04	A209450-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209450-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209450-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209450-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209450-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209450-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209450-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209450-002	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209450-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209450-002	AB	1	`6a51e52b5d6a…`

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 2 of 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lubiprostone	LUBIPROSTONE	Proficient Rx LP	34c547c4-4c29-45a9-97c7-a828bf2ecde0	2023-08-01	Warnings, Adverse reactions	Name fallback brand name: Lubiprostone generic name: LUBIPROSTONE
Lubiprostone	LUBIPROSTONE	Proficient Rx LP	a368117c-0e80-4dbc-a0a7-9b88dbfeece3	2023-08-01	Warnings, Adverse reactions	Name fallback brand name: Lubiprostone generic name: LUBIPROSTONE
Lubiprostone	LUBIPROSTONE	Proficient Rx LP	ea61ffd1-0610-4264-b964-00a9f4485d36	2023-08-01	Warnings, Adverse reactions	Name fallback brand name: Lubiprostone generic name: LUBIPROSTONE
Lubiprostone	LUBIPROSTONE	Zydus Pharmaceuticals USA Inc.	6c11a204-6831-4269-a3c4-1702ed83f74b	2023-03-27	Warnings, Adverse reactions	Name fallback brand name: Lubiprostone generic name: LUBIPROSTONE
Lubiprostone	LUBIPROSTONE	Teva Pharmaceuticals, Inc.	e17b521e-2c25-4bef-82f9-7916fa79bca4	2022-05-27	Warnings, Adverse reactions	Name fallback brand name: Lubiprostone generic name: LUBIPROSTONE

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-475	Lubiprostone	Lubiprostone	AvKARE	ANDA	Current
42291-476	Lubiprostone	Lubiprostone	AvKARE	ANDA	Current
65162-841	Lubiprostone	Lubiprostone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-841	Lubiprostone	Lubiprostone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-842	Lubiprostone	Lubiprostone	Amneal Pharmaceuticals LLC	ANDA	Current
65162-842	Lubiprostone	Lubiprostone	Amneal Pharmaceuticals LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67809	ORIG	2021-06-15