Application 091124

Type: ANDA
Sponsor: LUPIN LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ESZOPICLONE	ESZOPICLONE	TABLET;ORAL	1MG	No	No
002	ESZOPICLONE	ESZOPICLONE	TABLET;ORAL	2MG	No	No
003	ESZOPICLONE	ESZOPICLONE	TABLET;ORAL	3MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A091124-001	ESZOPICLONE	ESZOPICLONE	1MG	TABLET / ORAL	2011-09-13
A091124-002	ESZOPICLONE	ESZOPICLONE	2MG	TABLET / ORAL	2011-09-13
A091124-003	ESZOPICLONE	ESZOPICLONE	3MG	TABLET / ORAL	2011-09-13

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 4 · 126 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	A091124-001	ESZOPICLONE	1MG	TABLET / ORAL		2011-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091124-002	ESZOPICLONE	2MG	TABLET / ORAL		2011-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091124-003	ESZOPICLONE	3MG	TABLET / ORAL		2011-09-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091124-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091124-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091124-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091124-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091124-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091124-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091124-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091124-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091124-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-09-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091124-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091124-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091124-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-09-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091124-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-09-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091124-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-09-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091124-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-09-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091124-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-09-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091124-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-09-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091124-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-09-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091124-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-09-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091124-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-09-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091124-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-09-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091124-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-09-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091124-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-09-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091124-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-09-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091124-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-09-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091124-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-09-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091124-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-09-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091124-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-09-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091124-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-09-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091124-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-09-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091124-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-09-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091124-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-09-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091124-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-09-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091124-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-09-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091124-002	ESZOPICLONE	2MG	TABLET / ORAL	AB	2011-09-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091124-003	ESZOPICLONE	3MG	TABLET / ORAL	AB	2011-09-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091124-001	ESZOPICLONE	1MG	TABLET / ORAL	AB	2011-09-13	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091124-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091124-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091124-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091124-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091124-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091124-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091124-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091124-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091124-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091124-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091124-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091124-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091124-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091124-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091124-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091124-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091124-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091124-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091124-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091124-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091124-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091124-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091124-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091124-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091124-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091124-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091124-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091124-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091124-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091124-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091124-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091124-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091124-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091124-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091124-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091124-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091124-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091124-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091124-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091124-001	AB	1	`8072bd15b7f6…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eszopiclone	ESZOPICLONE	PD-Rx Pharmaceuticals, Inc.	4832cfbf-a540-46af-bb7d-3ba8e6bc783e	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091124 application number: ANDA091124 ndc (product): 43063-795
ESZOPICLONE	ESZOPICLONE	DIRECT RX	a7bd3e3c-26e9-07e7-e053-2995a90a9ca5	2025-01-17	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 091124 application number: ANDA091124 ndc (product): 72189-099
Eszopiclone	ESZOPICLONE	Advanced Rx of Tennessee, LLC	b39dc64d-adc9-742e-e053-2a95a90ad18b	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091124 application number: ANDA091124 ndc (product): 80425-0098
Eszopiclone	ESZOPICLONE	Advanced Rx Pharmacy of Tennessee, LLC	b4f272eb-02e3-415a-e053-2a95a90a428f	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091124 application number: ANDA091124 ndc (product): 80425-0115
Eszopiclone	ESZOPICLONE	Lupin Pharmaceuticals, Inc.	7068c455-691e-4c56-9857-b7b4e13f4784	2024-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091124 application number: ANDA091124 ndc (product): 68180-323 ndc (product): 68180-324 ndc (product): 68180-322

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43063-795	Eszopiclone	Eszopiclone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-795	Eszopiclone	Eszopiclone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-795	Eszopiclone	Eszopiclone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-795	Eszopiclone	Eszopiclone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-1748	Eszopiclone	Eszopiclone	A-S Medication Solutions	ANDA	Current
68180-322	Eszopiclone	Eszopiclone	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-322	Eszopiclone	Eszopiclone	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-323	Eszopiclone	Eszopiclone	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-323	Eszopiclone	Eszopiclone	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-324	Eszopiclone	Eszopiclone	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-324	Eszopiclone	Eszopiclone	Lupin Pharmaceuticals, Inc.	ANDA	Current
70518-2979	Eszopiclone	Eszopiclone	REMEDYREPACK INC.	ANDA	Current
72189-099	ESZOPICLONE	ESZOPICLONE	DIRECT RX	ANDA	Current
72189-099	ESZOPICLONE	ESZOPICLONE	DIRECT RX	ANDA	Current
80425-0098	Lunesta	Eszopiclone 1mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0098	Eszopiclone	Eszopiclone	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0098	Eszopiclone	Eszopiclone	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0115	Lunesta	Eszopiclone 3mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0115	Eszopiclone	Eszopiclone	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0115	Eszopiclone	Eszopiclone	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0115	Eszopiclone	Eszopiclone	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current